Back to resultsStudy of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)
Primary Purpose
Myelofibrosis (MF)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Navitoclax
Ruxolitinib
Best Available Therapy (BAT)
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis (MF) focused on measuring ABT-263, Navitoclax, Ruxolitinib, MF, Myelofibrosis, Cancer
Eligibility Criteria
Inclusion Criteria:
Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.
-- Has at least 2 symptoms each with an average score >= 3 or an average total score of >= 12, as measured by the MFSAF v4.0.
- Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.
- Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
Must currently be on treatment or have received prior treatment with a single Janus Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in addition to the minimum splenomegaly and symptom burden also required for eligibility):
- Treatment with ruxolitinib for >= 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.
Treatment with ruxolitinib for < 24 weeks with documented disease progression while on therapy as defined by any of the following:
- Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
- A >= 100% increase in the palpable distance below the LCM in participants with measurable spleen distance 5 to 10 centimeters (cm) prior to the initiation of ruxolitinib.
- A >= 50% increase in the palpable distance below the LCM in participants with measurable spleen distance > 10 cm prior to the initiation of ruxolitinib.
- A spleen volume increase of >= 25% (as assessed by Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan) in participants with a spleen volume assessment prior to the initiation of ruxolitinib.
- Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for >= 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of >= 30 mg but unable to reduce dose further due to lack of efficacy.
Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Splenomegaly defined as palpable spleen measurement >= 5 cm below left costal margin or spleen volume >= 450 cm3 as assessed centrally by MRI or CT scan.
- Baseline platelet count >= 100 × 10^9/L.
Exclusion Criteria:
- Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, or prior use of > 1 JAK2 inhibitor or stem cell transplant.
- Eligible for stem cell transplantation at the time of study entry.
- Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).
- Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).
Sites / Locations
- Ironwood Cancer & Res Ctr /ID# 222162Recruiting
- Highlands Oncology Group, PA /ID# 221826Recruiting
- Moores Cancer Center at UC San Diego /ID# 219009Recruiting
- Long Beach Memorial Medical Ct /ID# 224542Recruiting
- Icri /Id# 221967Recruiting
- St. Mary's Hospital Regional Cancer Center /ID# 224229Recruiting
- Augusta University Georgia Cancer Center /ID# 219051Recruiting
- Columbus Regional Research Institute /ID# 224410Recruiting
- Northwest Oncology & Hematology - Elk Grove Village /ID# 222818Recruiting
- Loyola University Medical Ctr /ID# 219048Recruiting
- Indiana Blood & Marrow Transpl /ID# 221587Recruiting
- Tulane Medical Center - New Orleans /ID# 222940
- Ochsner Clinic Foundation-New Orleans /ID# 222777Recruiting
- American Oncology Partners of Maryland, PA /ID# 222836Recruiting
- Dana-Farber Cancer Institute /ID# 218998Recruiting
- University of Michigan /ID# 218463Recruiting
- Henry Ford Health System /ID# 221190Recruiting
- William Beaumont Hospital /ID# 222705Recruiting
- Saint Louis University Cancer Center /ID# 222287Recruiting
- Summit Medical Group-Florham Park /ID# 222620Recruiting
- Hackensack Univ Med Ctr /ID# 219047Recruiting
- The Cancer Institute at St. Francis Hospital /ID# 231782Recruiting
- Manhattan Hematology Oncology MHO Associates /ID# 223193Recruiting
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081Recruiting
- Wake Forest Baptist Medical Center /ID# 222899Recruiting
- MetroHealth Medical Center /ID# 222650Recruiting
- Hospital of the University of Pennsylvania /ID# 219001Recruiting
- Fox Chase Cancer Center /ID# 223955Recruiting
- Houston Methodist Hospital /ID# 223103
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942
- Utah Cancer Specialists Salt Lake Clinic /ID# 221962Recruiting
- Virginia Cancer Specialists - Fairfax /ID# 223016Recruiting
- Providence Everett /ID# 223130
- Yakima Valley Memorial Hosp /ID# 224368Recruiting
- HSHS St. Vincent Hospital /ID# 224468Recruiting
- The Kinghorn Cancer Centre /ID# 221097Recruiting
- Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 223848Recruiting
- Calvary Mater Newcastle /ID# 224324Recruiting
- Alfred Health /ID# 221096Recruiting
- Royal Perth Hospital /ID# 221099Recruiting
- Universitaetsklinikum St. Poelten /ID# 221709Recruiting
- Ordensklinikum Linz GmbH Elisabethinen /ID# 220914Recruiting
- Klinikum Wels-Grieskirchen GmbH /ID# 220915Recruiting
- Medizinische Universitaet Graz /ID# 220919Recruiting
- Medizinische Universitaet Wien /ID# 220911Recruiting
- Hanusch Krankenhaus /ID# 220912Recruiting
- ZNA Cadix /ID# 221468Recruiting
- UCL Saint-Luc /ID# 224221Recruiting
- Grand Hopital de Charleroi /ID# 224827Recruiting
- UZ Gent /ID# 220841Recruiting
- AZ-Delta /ID# 221469Recruiting
- Vitaz /Id# 228150Recruiting
- UMHAT Alexandrovska EAD /ID# 231652Recruiting
- UMHAT Dr Georgi Stranski EAD /ID# 231650Recruiting
- Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649Recruiting
- UMHAT Sveti Ivan Rilski /ID# 231651Recruiting
- UMHAT Sveta Marina /ID# 234119Recruiting
- Juravinski Cancer Centre /ID# 220887Recruiting
- Ottawa Hospital Research Institute /ID# 238858Recruiting
- CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433Recruiting
- McGill University Health Center Research Institute /ID# 222614Recruiting
- Clinical Hospital Dubrava /ID# 230801Recruiting
- Klinicka bolnica Merkur /ID# 230799Recruiting
- Klinicki bolnicki centar Zagreb /ID# 230798
- Klinicki bolnicki centar Osijek /ID# 231503Recruiting
- Klinicki bolnicki centar Split /ID# 230800Recruiting
- Fakultni Nemocnice Brno /ID# 220959Recruiting
- Vseobecna fakultni nemocnice v Praze /ID# 220969
- Aalborg University Hospital /ID# 224391Recruiting
- Sjællands Universitetshospital /ID# 224456Recruiting
- HCL - Hopital Lyon Sud /ID# 222695Recruiting
- CHU NIMES - Hopital Caremeau /ID# 219128Recruiting
- CHU Bordeaux - Hopital Haut Leveque /ID# 222696Recruiting
- Hopital Avicenne - APHP /ID# 221287
- CHU de Nantes, Hotel Dieu -HME /ID# 219127Recruiting
- Centre Hospitalier de CHAMBERY /ID# 223771Recruiting
- Chu Angers /Id# 219129Recruiting
- AP-HP - Hopital Saint-Louis /ID# 221390Recruiting
- Universitatsklinikum Mannheim /ID# 221529Recruiting
- Stauferklinikum Schwaebisch Gmuend /ID# 223948Recruiting
- Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 225025
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346Recruiting
- Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695
- Klinikum Chemnitz gGmbH /ID# 224575Recruiting
- OncoResearch Lerchenfeld GmbH /ID# 225034Recruiting
- Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221526Recruiting
- Universitaetsmedizin Rostock /ID# 224157Recruiting
- General Hospital of Athens Laiko /ID# 221175Recruiting
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179Recruiting
- University General Hospital of Patras /ID# 221178Recruiting
- General Hospital of Thessaloniki George Papanikolaou /ID# 221463Recruiting
- Szegedi Tudomanyegyetem /ID# 220955Recruiting
- Fejer Megyei Szent Gyorgy Korhaz /ID# 220949Recruiting
- Debreceni Egyetem Klinikai Kozpont /ID# 220947Recruiting
- Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946Recruiting
- The Chaim Sheba Medical Center /ID# 219136Recruiting
- Tel Aviv Sourasky Medical Center /ID# 219135Recruiting
- Hadassah Medical Center-Hebrew University /ID# 219111Recruiting
- HaEmek Medical Center /ID# 220839Recruiting
- Assuta Ashdod Medical Center /ID# 225281Recruiting
- Assaf Harofeh Medical Center /ID# 222972Recruiting
- Rambam Health Care Campus /ID# 219121
- The Lady Davis Carmel Medical Center /ID# 222973Recruiting
- Hadassah Mt. Scopus /ID# 253394Recruiting
- Galilee Medical Center /ID# 225280Recruiting
- Rabin Medical Center /ID# 219139Recruiting
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087Recruiting
- ASST Monza/Ospedale San Gerardo /ID# 225113Recruiting
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 238438Recruiting
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077Recruiting
- A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089Recruiting
- Azienda Ospedaliero Universitaria Careggi /ID# 219090Recruiting
- Azienda Ospedaliera Universitaria Federico II /ID# 224673Recruiting
- Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078Recruiting
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220Recruiting
- A.O.U. Citta della Salute e della Scienza di Torino /ID# 221223Recruiting
- Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241Recruiting
- ASST Sette Laghi /ID# 234183Recruiting
- Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079Recruiting
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150Recruiting
- Fujita Health University Hospital /ID# 221598Recruiting
- Chiba University Hospital /ID# 224546Recruiting
- National Cancer Center Hospital East /ID# 226653Recruiting
- Ehime University Hospital /ID# 221158Recruiting
- Kyushu University Hospital /ID# 221606Recruiting
- Fukushima Medical University Hospital /ID# 221877Recruiting
- Gifu University Hospital /ID# 224371Recruiting
- Sapporo Hokuyu Hospital /ID# 221149Recruiting
- Kobe City Medical Center General Hospital /ID# 221156Recruiting
- Kanazawa University Hospital /ID# 223028Recruiting
- Iwate Medical University Hospital /ID# 222044Recruiting
- Shonan Kamakura General Hospital /ID# 223030Recruiting
- Kumamoto Shinto General Hospital /ID# 255645Recruiting
- Kyoto University Hospital /ID# 223008Recruiting
- Mie University Hospital /ID# 221665Recruiting
- University of Miyazaki Hospital /ID# 221821Recruiting
- Niigata University Medical & Dental Hospital /ID# 223034Recruiting
- Kurashiki Central Hospital /ID# 221690Recruiting
- Kansai Medical University Hospital /ID# 257289Recruiting
- Osaka University Hospital /ID# 221159Recruiting
- Dokkyo Medical University Saitama Medical Center /ID# 222334Recruiting
- Juntendo University Shizuoka Hospital /ID# 221780Recruiting
- Juntendo University Hospital /ID# 221154Recruiting
- Nippon Medical School Hospital /ID# 221676Recruiting
- The Institute of Medical Science the University of Tokyo Hospital /ID# 257944Recruiting
- Tokyo Medical University Hospital /ID# 221540Recruiting
- Tokyo Metropolitan Bokutoh Hospital /ID# 254774Recruiting
- University of Yamanashi Hospital /ID# 221706Recruiting
- Pusan National University Hospital /ID# 220980Recruiting
- Gachon University Gil Medical Center /ID# 220972Recruiting
- Seoul National University Hospital /ID# 219060Recruiting
- Samsung Medical Center /ID# 221091Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219061Recruiting
- Aotearoa Clinical Trials /ID# 232201Recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161Recruiting
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124Recruiting
- SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160
- LUX MED Onkologia - Szpital Szamocka /ID# 221265
- Uniwersyteckie Centrum Kliniczne /ID# 221298Recruiting
- ARS-MEDICAL Sp. z o.o. /ID# 238336Recruiting
- Pratia Onkologia Katowice /ID# 224526
- Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031Recruiting
- MTZ Clinical Research Powered by Pratia /ID# 221759Recruiting
- Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281Recruiting
- Moscow State budget healthcare /ID# 221116
- Hospital n.a. V.V. Veresaev /ID# 225221
- Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115
- Almazov National Medical Research Centre /ID# 221114
- Tula Regional Clinical Hospital /ID# 221302
- University Clinical Center Serbia /ID# 231058Recruiting
- Clin Hosp Ctr Bezanijska Kosa /ID# 231059Recruiting
- Clinical Center Vojvodina /ID# 231057Recruiting
- Wits Clinical Research Site /ID# 231554Recruiting
- Alberts Cellular Therapy /ID# 231556Recruiting
- Hospital Clínico Universitario de Santiago-CHUS /ID# 221616Recruiting
- Hospital Universitario Central de Asturias /ID# 224815Recruiting
- Hospital Universitario Germans Trias i Pujol /ID# 233727Recruiting
- Hospital Universitario Dr. Negrin /ID# 220923Recruiting
- Hospital Universitario A Coruna - CHUAC /ID# 224617Recruiting
- Hospital Parc de Salut del Mar /ID# 220922Recruiting
- Hospital Universitario Vall d'Hebron /ID# 240979Recruiting
- Hospital Universitario Virgen de las Nieves /ID# 253936Recruiting
- Hospital Universitario 12 de Octubre /ID# 233726Recruiting
- Hospital Universitario La Paz /ID# 224813Recruiting
- Hospital Regional Universitario de Malaga /ID# 221906
- Hospital Universitario de Salamanca /ID# 221904
- Hospital Universitario Virgen del Rocio /ID# 221932Recruiting
- Hospital Clinico Universitario de Valencia /ID# 220920Recruiting
- Skane University Hospital Lund /ID# 220834Recruiting
- Universitätsspital Basel /ID# 221261
- Inselspital, Universitätsspital Bern /ID# 223439
- Kaohsiung Chang Gung Memorial Hospital /ID# 218985Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980Recruiting
- China Medical University Hospital /ID# 218979Recruiting
- Chi Mei Hospital - Liouying /ID# 221144Recruiting
- Taipei Veterans General Hosp /ID# 221147Recruiting
- Linkou Chang Gung Memorial Hospital /ID# 218982Recruiting
- Gulhane Askeri Tip Academy /ID# 224568Recruiting
- Trakya University Medical Facu /ID# 224572Recruiting
- Ege University Medical Faculty /ID# 224570Recruiting
- Mersin University Medical /ID# 224571Recruiting
- Ondokuz mayis University Facul /ID# 224567Recruiting
- United Lincolnshire Hospitals NHS Trust /ID# 224613Recruiting
- Guys and St Thomas NHS Foundation Trust /ID# 221041Recruiting
- James Paget University Hospitals NHS Foundation Trust /ID# 221219Recruiting
- University Hospitals Birmingham NHS Foundation Trust /ID# 221334Recruiting
- NHS Lothian /ID# 224378Recruiting
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Navitoclax + Ruxolitinib
Arm B: Best Available Therapy (BAT)
Arm Description
Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
Participants will receive one of the BAT options, per the investigator's discretion.
Outcomes
Primary Outcome Measures
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
Secondary Outcome Measures
Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis
Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.
Percentage of Participants with Anemia Response
Anemia response per International Working Group (IWG) criteria will be assessed.
Percentage of Participants with Overall Survival
Overall survival is defined as the time from start of study to the date of death from any cause.
Percentage of Participants with Leukemia-free Survival
Leukemia free survival is the time from start of study to the date of development of leukemia.
Percentage of Participants with Change in Fatigue
Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.
Time to Deterioration of Physical Functioning
Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.
Percentage of Participants with at Least 50% Reduction in TSS
At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04468984
Brief Title
Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
Acronym
TRANSFORM-2
Official Title
A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
January 2, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF.
Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world.
In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis (MF)
Keywords
ABT-263, Navitoclax, Ruxolitinib, MF, Myelofibrosis, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Navitoclax + Ruxolitinib
Arm Type
Experimental
Arm Description
Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
Arm Title
Arm B: Best Available Therapy (BAT)
Arm Type
Active Comparator
Arm Description
Participants will receive one of the BAT options, per the investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Navitoclax
Other Intervention Name(s)
ABT-263
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Best Available Therapy (BAT)
Intervention Description
Tablet/Capsule; Oral or Solution for Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
Description
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
Description
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time Frame
Baseline (Week 0) Up to Week 24
Title
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
Description
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
Time Frame
Baseline (Week 0) Up to Week 97
Title
Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis
Description
Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.
Time Frame
Baseline (Week 0) Up to Week 97
Title
Percentage of Participants with Anemia Response
Description
Anemia response per International Working Group (IWG) criteria will be assessed.
Time Frame
Baseline (Week 0) Up to Week 97
Title
Percentage of Participants with Overall Survival
Description
Overall survival is defined as the time from start of study to the date of death from any cause.
Time Frame
Last Visit Up to 5 Years
Title
Percentage of Participants with Leukemia-free Survival
Description
Leukemia free survival is the time from start of study to the date of development of leukemia.
Time Frame
Last Visit Up to 5 Years
Title
Percentage of Participants with Change in Fatigue
Description
Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.
Time Frame
Baseline (Week 0) Up to Week 24
Title
Time to Deterioration of Physical Functioning
Description
Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.
Time Frame
Baseline (Week 0) Up to Week 97
Title
Percentage of Participants with at Least 50% Reduction in TSS
Description
At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.
Time Frame
Baseline (Week 0) Up to Week 97
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.
-- Has at least 2 symptoms each with an average score >= 3 or an average total score of >= 12, as measured by the MFSAF v4.0.
Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.
Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
Must currently be on treatment or have received prior treatment with a single Janus Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in addition to the minimum splenomegaly and symptom burden also required for eligibility):
Treatment with ruxolitinib for >= 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.
Treatment with ruxolitinib for < 24 weeks with documented disease progression while on therapy as defined by any of the following:
Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
A >= 100% increase in the palpable distance below the LCM in participants with measurable spleen distance 5 to 10 centimeters (cm) prior to the initiation of ruxolitinib.
A >= 50% increase in the palpable distance below the LCM in participants with measurable spleen distance > 10 cm prior to the initiation of ruxolitinib.
A spleen volume increase of >= 25% (as assessed by Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan) in participants with a spleen volume assessment prior to the initiation of ruxolitinib.
Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for >= 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of >= 30 mg but unable to reduce dose further due to lack of efficacy.
Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Splenomegaly defined as palpable spleen measurement >= 5 cm below left costal margin or spleen volume >= 450 cm3 as assessed centrally by MRI or CT scan.
Baseline platelet count >= 100 × 10^9/L.
Exclusion Criteria:
Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, or prior use of > 1 JAK2 inhibitor or stem cell transplant.
Eligible for stem cell transplantation at the time of study entry.
Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).
Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Res Ctr /ID# 222162
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-5665
Country
United States
Individual Site Status
Recruiting
Facility Name
Highlands Oncology Group, PA /ID# 221826
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Name
Moores Cancer Center at UC San Diego /ID# 219009
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Memorial Medical Ct /ID# 224542
City
Long Beach
State/Province
California
ZIP/Postal Code
90806-1701
Country
United States
Individual Site Status
Recruiting
Facility Name
Icri /Id# 221967
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Mary's Hospital Regional Cancer Center /ID# 224229
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501-6132
Country
United States
Individual Site Status
Recruiting
Facility Name
Augusta University Georgia Cancer Center /ID# 219051
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-0003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Columbus Regional Research Institute /ID# 224410
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8915
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Oncology & Hematology - Elk Grove Village /ID# 222818
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007-3361
Country
United States
Individual Site Status
Recruiting
Facility Name
Loyola University Medical Ctr /ID# 219048
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana Blood & Marrow Transpl /ID# 221587
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane Medical Center - New Orleans /ID# 222940
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2600
Country
United States
Individual Site Status
Completed
Facility Name
Ochsner Clinic Foundation-New Orleans /ID# 222777
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA /ID# 222836
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute /ID# 218998
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Michigan /ID# 218463
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Henry Ford Health System /ID# 221190
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
William Beaumont Hospital /ID# 222705
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6710
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis University Cancer Center /ID# 222287
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-2539
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Medical Group-Florham Park /ID# 222620
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932-1049
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack Univ Med Ctr /ID# 219047
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
The Cancer Institute at St. Francis Hospital /ID# 231782
City
Greenvale
State/Province
New York
ZIP/Postal Code
11548-1219
Country
United States
Individual Site Status
Recruiting
Facility Name
Manhattan Hematology Oncology MHO Associates /ID# 223193
City
New York
State/Province
New York
ZIP/Postal Code
10016-6028
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center /ID# 222899
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
MetroHealth Medical Center /ID# 222650
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania /ID# 219001
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4238
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Fox Chase Cancer Center /ID# 223955
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Methodist Hospital /ID# 223103
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
Utah Cancer Specialists Salt Lake Clinic /ID# 221962
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists - Fairfax /ID# 223016
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Everett /ID# 223130
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Completed
Facility Name
Yakima Valley Memorial Hosp /ID# 224368
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902-6388
Country
United States
Individual Site Status
Recruiting
Facility Name
HSHS St. Vincent Hospital /ID# 224468
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Recruiting
Facility Name
The Kinghorn Cancer Centre /ID# 221097
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 223848
City
East Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle /ID# 224324
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health /ID# 221096
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Perth Hospital /ID# 221099
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum St. Poelten /ID# 221709
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen /ID# 220914
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen GmbH /ID# 220915
City
Wels
State/Province
Oberoesterreich
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz /ID# 220919
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien /ID# 220911
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hanusch Krankenhaus /ID# 220912
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
ZNA Cadix /ID# 221468
City
Antwerp
State/Province
Antwerpen
ZIP/Postal Code
2030
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UCL Saint-Luc /ID# 224221
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi /ID# 224827
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent /ID# 220841
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ-Delta /ID# 221469
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz /Id# 228150
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UMHAT Alexandrovska EAD /ID# 231652
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 231650
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sveti Ivan Rilski /ID# 231651
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sveta Marina /ID# 234119
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Juravinski Cancer Centre /ID# 220887
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ottawa Hospital Research Institute /ID# 238858
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
14188307474
Facility Name
McGill University Health Center Research Institute /ID# 222614
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Dubrava /ID# 230801
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicka bolnica Merkur /ID# 230799
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Zagreb /ID# 230798
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Klinicki bolnicki centar Osijek /ID# 231503
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Split /ID# 230800
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 220959
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 220969
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Completed
Facility Name
Aalborg University Hospital /ID# 224391
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sjællands Universitetshospital /ID# 224456
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
HCL - Hopital Lyon Sud /ID# 222695
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
CHU NIMES - Hopital Caremeau /ID# 219128
City
Nimes CEDEX 9
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 222696
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Avicenne - APHP /ID# 221287
City
Bobigny
State/Province
Ile-de-France
ZIP/Postal Code
93000
Country
France
Individual Site Status
Completed
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 219127
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de CHAMBERY /ID# 223771
City
Chambery
State/Province
Savoie
ZIP/Postal Code
73000
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Angers /Id# 219129
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Louis /ID# 221390
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Mannheim /ID# 221529
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Stauferklinikum Schwaebisch Gmuend /ID# 223948
City
Mutlangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Recruiting
Facility Name
Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 225025
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Individual Site Status
Completed
Facility Name
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Chemnitz gGmbH /ID# 224575
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
OncoResearch Lerchenfeld GmbH /ID# 225034
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221526
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Rostock /ID# 224157
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Laiko /ID# 221175
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Patras /ID# 221178
City
RION Patras Achaia
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Thessaloniki George Papanikolaou /ID# 221463
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem /ID# 220955
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejer Megyei Szent Gyorgy Korhaz /ID# 220949
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 220947
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Completed
Facility Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 219136
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 219135
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center-Hebrew University /ID# 219111
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
HaEmek Medical Center /ID# 220839
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Name
Assuta Ashdod Medical Center /ID# 225281
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Assaf Harofeh Medical Center /ID# 222972
City
Be'Er Ya'Akov
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus /ID# 219121
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Completed
Facility Name
The Lady Davis Carmel Medical Center /ID# 222973
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Mt. Scopus /ID# 253394
City
Jerusalem
ZIP/Postal Code
9765400
Country
Israel
Individual Site Status
Recruiting
Facility Name
Galilee Medical Center /ID# 225280
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 219139
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Monza/Ospedale San Gerardo /ID# 225113
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 238438
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 219090
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II /ID# 224673
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 221223
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Sette Laghi /ID# 234183
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital /ID# 221598
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital /ID# 224546
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East /ID# 226653
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ehime University Hospital /ID# 221158
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital /ID# 221606
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital /ID# 221877
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital /ID# 224371
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Hokuyu Hospital /ID# 221149
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital /ID# 221156
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital /ID# 223028
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital /ID# 222044
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shonan Kamakura General Hospital /ID# 223030
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto Shinto General Hospital /ID# 255645
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital /ID# 223008
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital /ID# 221665
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Miyazaki Hospital /ID# 221821
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital /ID# 223034
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital /ID# 221690
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital /ID# 257289
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+81-72-804-2808
Facility Name
Osaka University Hospital /ID# 221159
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Saitama Medical Center /ID# 222334
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Shizuoka Hospital /ID# 221780
City
Izunokuni-shi
State/Province
Shizuoka
ZIP/Postal Code
410-2295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital /ID# 221154
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Hospital /ID# 221676
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Institute of Medical Science the University of Tokyo Hospital /ID# 257944
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8639
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital /ID# 221540
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Bokutoh Hospital /ID# 254774
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Yamanashi Hospital /ID# 221706
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3821
Country
Japan
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital /ID# 220980
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center /ID# 220972
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 219060
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center /ID# 221091
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219061
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Aotearoa Clinical Trials /ID# 232201
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Completed
Facility Name
LUX MED Onkologia - Szpital Szamocka /ID# 221265
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersyteckie Centrum Kliniczne /ID# 221298
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
ARS-MEDICAL Sp. z o.o. /ID# 238336
City
Pila
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice /ID# 224526
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Completed
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
MTZ Clinical Research Powered by Pratia /ID# 221759
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Moscow State budget healthcare /ID# 221116
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Hospital n.a. V.V. Veresaev /ID# 225221
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115
City
Sankt-Peterburg
ZIP/Postal Code
191024
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Almazov National Medical Research Centre /ID# 221114
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Tula Regional Clinical Hospital /ID# 221302
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Individual Site Status
Completed
Facility Name
University Clinical Center Serbia /ID# 231058
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 231059
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Vojvodina /ID# 231057
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Wits Clinical Research Site /ID# 231554
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Alberts Cellular Therapy /ID# 231556
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0044
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 221616
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias /ID# 224815
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 233727
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Dr. Negrin /ID# 220923
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 224617
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Parc de Salut del Mar /ID# 220922
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 240979
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 253936
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 233726
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz /ID# 224813
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga /ID# 221906
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario de Salamanca /ID# 221904
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Virgen del Rocio /ID# 221932
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia /ID# 220920
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skane University Hospital Lund /ID# 220834
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
SE 221 41
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitätsspital Basel /ID# 221261
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Completed
Facility Name
Inselspital, Universitätsspital Bern /ID# 223439
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Completed
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 218985
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital /ID# 218979
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi Mei Hospital - Liouying /ID# 221144
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hosp /ID# 221147
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 218982
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Gulhane Askeri Tip Academy /ID# 224568
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Facu /ID# 224572
City
Edirne, Istanbul
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty /ID# 224570
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin University Medical /ID# 224571
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz mayis University Facul /ID# 224567
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
United Lincolnshire Hospitals NHS Trust /ID# 224613
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN2 4AX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 221041
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
James Paget University Hospitals NHS Foundation Trust /ID# 221219
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 221334
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Lothian /ID# 224378
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
We'll reach out to this number within 24 hrs