Back to resultsA Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis (REFINE)
Primary Purpose
Myelofibrosis (MF)
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib
Navitoclax
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis (MF) focused on measuring Post-polycythemia vera MF (PPV-MF), Post-essential thrombocythemia (PET-MF), ruxolitinib, navitoclax, splenic volume, Primary Myelofibrosis, Jakafi, enlarged spleen, splenomegaly, ABT 263, bone marrow fibrosis
Eligibility Criteria
Inclusion Criteria:
- Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
- Participant must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2.
Prior treatment must meet at least one of the following criteria:
Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria:
Ruxolitinib treatment must meet at least one of the following criteria:
- Ruxolitinib treatment for >=24 weeks with lack of efficacy defined as a lack of spleen response (refractory) or a loss of spleen or symptom response (relapsed)
- Ruxolitinib treatment for <24 weeks with documented disease progression on spleen measurements while on ruxolitinib as defined in the protocol:
- Ruxolitinib treatment for >=28 days with intolerance defined as new red blood cell 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.
- If receiving ruxolitinib at the time of screening, must currently be on a stable dose >=10 mg twice daily of ruxolitinib for >=4 weeks prior to the 1st dose of navitoclax.
- Participant has at least 2 symptoms each with a score >=3 or a total score of >=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR
Prior treatment with a JAK-2 inhibitor and meet one of the following criteria:
- Prior treatment with a JAK-2 inhibitor for at least 12 weeks
- Prior treatment with a JAK-2 inhibitor for >=28 days complicated by either development of red blood cell transfusion requirement (at least 2 units/month for 2 months) OR Grade >= 3 adverse events of thrombocytopenia, anemia, hematoma and/or hemorrhage while on JAK-2 inhibitor treatment; OR
No prior treatment with a JAK-2 or BET inhibitor:
- Participant has at least 2 symptoms each with a score >=3 or a total score of >= 12, as measured by the MFSAF v4.0 on at least 4 out of 7 days during screening prior to study drug dosing.
- Participant has splenomegaly as defined in the protocol.
- Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
Exclusion Criteria:
- Splenic irradiation within 6 months prior to screening, or prior splenectomy.
- Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy).
- Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function within 3 days prior to the first dose of study drug or during the study treatment period with the exception of low dose aspirin (up to 100 mg/day) and low-molecular-weight heparin.
- Prior therapy with a BH3 mimetic compound or stem cell transplantation.
- Participant has received strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin) or moderate CYP3A inhibitors (e.g., fluconazole) within 14 days prior to the administration of the first dose of study drug.
Sites / Locations
- UAB Comprehensive Cancer Cente /ID# 165464
- City of Hope /ID# 221395
- St. Joseph Heritage Healthcare /ID# 230935
- Moore UC San Diego Cancer Center /ID# 164084
- Long Beach Memorial Medical Ct /ID# 230148
- Universtiy of Southern California /ID# 164095
- Ventura Oncology /ID# 230940
- St Joseph Heritage Healthcare /ID# 230936
- Icri /Id# 222546
- Colorado Blood Cancer Institute /ID# 224250
- Eastern Connecticut Hematology and Oncology Associates /ID# 230918
- Holy Cross Hospital /ID# 230922
- Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548
- Mayo Clinic /ID# 164201
- Cancer Specialists of North Florida /ID# 230917
- Ocala Oncology Florida Cancer Affiliates /ID# 230927
- Moffitt Cancer Center /ID# 164082
- University Cancer & Blood Center /ID# 230939
- University of Chicago Medicine /ID# 164115
- Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536
- Carle Cancer Institute /ID# 230571
- Fort Wayne Medical Oncology /ID# 230919
- Indiana Blood & Marrow Transpl /ID# 165075
- Community Health Network /ID# 230915
- Memorial Hospital of South Bend /ID# 230912
- Pontchartrain Cancer Center /ID# 230932
- The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299
- Frederick Health /ID# 230920
- Dana-Farber Cancer Institute /ID# 162675
- Southcoast Health Cancer Center /ID# 230934
- University of Massachusetts Wo /ID# 222547
- Henry Ford Hospital /ID# 162682
- Ascension Providence Southfield Cancer Center /ID# 223876
- Central Care Cancer Center /ID# 230913
- Capital Region Medical Center /ID# 232627
- MidAmerica Division, Inc. /ID# 222058
- Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924
- Comprehensive Cancer Centers of Nevada /ID# 230916
- New Jersey Cancer Care & Blood Disorders /ID# 230925
- Summit Medical Group /ID# 230937
- Weill Cornell Medical College /ID# 162679
- Southeastern Medical Oncology Center /ID# 230954
- Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938
- The Ohio State University /ID# 217402
- OhioHealth /ID# 230928
- Oklahoma Cancer Specialists /ID# 230929
- Bend Memorial Clinic /ID# 224184
- Oregon Oncology Specialists /ID# 230931
- Gettysburg Cancer Center /ID# 230921
- West Penn Hospital /ID# 222618
- Medical University of South Carolina /ID# 222597
- St Francis Cancer Center /ID# 230254
- Sanford Cancer Center /ID# 230933
- Avera Cancer Institute /ID# 222364
- Prairie Lakes Healthcare System /ID# 224358
- Tennessee Oncology-Nashville Centennial /ID# 221410
- Texas Oncology - West Texas /ID# 224784
- Mary Crowley Cancer Research /ID# 230923
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159
- Oncology Consultants /ID# 230930
- MD Anderson Cancer Center at Texas Medical Center /ID# 162683
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094
- Community Cancer Trials of Utah /ID# 230914
- Utah Cancer Specialists Salt Lake Clinic /ID# 222806
- University of Utah /ID# 164116
- Hematology Oncology Associates of Fredericksburg /ID# 231372
- Northwest Medical Specialties /ID# 230926
- The Kinghorn Cancer Centre /ID# 214657
- Barwon Health /ID# 222430
- Peter MacCallum Cancer Ctr /ID# 218352
- Alfred Health /ID# 215545
- Fiona Stanley Hospital /ID# 216809
- AZ Klina /ID# 230592
- UMHAT Sveti Ivan Rilski /ID# 231163
- UMHAT Sveta Marina /ID# 231411
- University of Alberta Hospital - Division of Hematology /ID# 217698
- Princess Margaret Cancer Centre /ID# 214483
- Jewish General Hospital /ID# 217586
- McGill University Health Center Research Institute /ID# 223976
- Klinicka bolnica Dubrava Zagreb /ID# 230504
- Klinicka bolnica Merkur /ID# 230599
- Klinicki bolnicki centar Zagreb /ID# 230602
- Klinicki bolnicki centar Split /ID# 230601
- Centre Hospitalier de CHAMBERY /ID# 230889
- CHU de Nimes /ID# 230888
- AP-HP - Hopital Necker /ID# 230900
- Hopital Saint Louis /ID# 230887
- General Hospital of Athens Laiko /ID# 230394
- University General Hospital Attikon /ID# 230395
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306
- Semmelweis Egyetem /ID# 230518
- Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585
- Hadassah Medical Center-Hebrew University /ID# 230310
- Assuta Ashdod Medical Center /ID# 230396
- Galilee Medical Center /ID# 230397
- Tel Aviv Sourasky Medical Center /ID# 230311
- A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553
- ASST Papa Giovanni XXIII /ID# 214900
- A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012
- ASST Spedali civili di Brescia /ID# 230420
- A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549
- Azienda Ospedaliero Universitaria Careggi /ID# 214555
- Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011
- ASST Sette Laghi /ID# 214551
- Fujita Health University Hospital /ID# 221539
- Aomori Prefectural Central Hospital /ID# 221773
- Kyushu University Hospital /ID# 222691
- Keiyukai Daini Hospital /ID# 222693
- Kansai Medical University Hospital /ID# 222690
- Kindai University Hospital /ID# 222689
- Dokkyo Medical University Saitama Medical Center /ID# 222332
- Juntendo University Hospital /ID# 221484
- Nippon Medical School Hospital /ID# 222692
- University of Yamanashi Hospital /ID# 221700
- Seoul National University Hospital /ID# 230380
- Samsung Medical Center /ID# 230381
- ARS-MEDICAL Sp. z o.o. /ID# 230809
- VA Caribbean Healthcare System /ID# 222416
- Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544
- City Clinical Hospital named after S.P. Botkin /ID# 230508
- Leningrad Regional Clinical Hospital /ID# 230507
- Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506
- University Clinical Center Serbia /ID# 230629
- Clin Hosp Ctr Bezanijska Kosa /ID# 230681
- University Clinical Center Kragujevac /ID# 230550
- Clinical Center Vojvodina /ID# 230525
- Hospital Universitario Central de Asturias /ID# 230884
- Hospital Universitario Germans Trias i Pujol /ID# 214704
- Hospital Regional de Malaga /ID# 230858
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718
- Hospital Universitario Vall d'Hebron /ID# 222415
- Hospital Clinic de Barcelona /ID# 231538
- Hospital General Universitario Gregorio Maranon /ID# 214676
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719
- Hospital Universitario 12 de Octubre /ID# 214710
- Hospital Universitario Virgen de la Victoria /ID# 214709
- Kaohsiung Chang Gung Memorial Hospital /ID# 230371
- National Cheng Kung University Hospital /ID# 230372
- Ankara Universitesi Fakultesi /ID# 230317
- Adnan Menderes University /ID# 230777
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318
- Dokuz Eylul University Medical Faculty /ID# 231321
- Ondokuz mayis University Facul /ID# 230314
- Guy's and St Thomas' NHS Foundation Trust /ID# 164110
- Oxford Univ Hosp NHS Trust /ID# 214503
- Belfast Health and Social Care Trust /ID# 216991
- The Christie Hospital /ID# 164111
- Aneurin Bevan University Health Board /ID# 230332
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Navitoclax + ruxolitinib
Navitoclax
Arm Description
Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
Participants will be administered various doses of navitoclax once daily (QD)
Outcomes
Primary Outcome Measures
Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
Secondary Outcome Measures
Percentage of participants achieving 50% Reduction in Total System Score (TSS)
TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.
Anemia Response
The anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
Change in Grade of Bone Marrow Fibrosis
Bone marrow grading is assessed according to the European Consensus Grading System.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03222609
Brief Title
A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
Acronym
REFINE
Official Title
A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
February 2, 2029 (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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis (MF)
Keywords
Post-polycythemia vera MF (PPV-MF), Post-essential thrombocythemia (PET-MF), ruxolitinib, navitoclax, splenic volume, Primary Myelofibrosis, Jakafi, enlarged spleen, splenomegaly, ABT 263, bone marrow fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navitoclax + ruxolitinib
Arm Type
Experimental
Arm Description
Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
Arm Title
Navitoclax
Arm Type
Experimental
Arm Description
Participants will be administered various doses of navitoclax once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
Jakafi
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Navitoclax
Other Intervention Name(s)
ABT-263
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline
Description
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
Time Frame
From Baseline (Week 0) through Week 24
Secondary Outcome Measure Information:
Title
Percentage of participants achieving 50% Reduction in Total System Score (TSS)
Description
TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.
Time Frame
From Baseline (Week 0) through Week 24
Title
Anemia Response
Description
The anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
Time Frame
Every 12 weeks up to approximately 96 weeks
Title
Change in Grade of Bone Marrow Fibrosis
Description
Bone marrow grading is assessed according to the European Consensus Grading System.
Time Frame
Through Week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
Participant must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry.
Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2.
Prior treatment must meet at least one of the following criteria:
Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria:
Ruxolitinib treatment must meet at least one of the following criteria:
Ruxolitinib treatment for >=24 weeks with lack of efficacy defined as a lack of spleen response (refractory) or a loss of spleen or symptom response (relapsed)
Ruxolitinib treatment for <24 weeks with documented disease progression on spleen measurements while on ruxolitinib as defined in the protocol:
Ruxolitinib treatment for >=28 days with intolerance defined as new red blood cell 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.
If receiving ruxolitinib at the time of screening, must currently be on a stable dose >=10 mg twice daily of ruxolitinib for >=4 weeks prior to the 1st dose of navitoclax.
Participant has at least 2 symptoms each with a score >=3 or a total score of >=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR
Prior treatment with a JAK-2 inhibitor and meet one of the following criteria:
Prior treatment with a JAK-2 inhibitor for at least 12 weeks
Prior treatment with a JAK-2 inhibitor for >=28 days complicated by either development of red blood cell transfusion requirement (at least 2 units/month for 2 months) OR Grade >= 3 adverse events of thrombocytopenia, anemia, hematoma and/or hemorrhage while on JAK-2 inhibitor treatment; OR
No prior treatment with a JAK-2 or BET inhibitor:
Participant has at least 2 symptoms each with a score >=3 or a total score of >= 12, as measured by the MFSAF v4.0 on at least 4 out of 7 days during screening prior to study drug dosing.
Participant has splenomegaly as defined in the protocol.
Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
Exclusion Criteria:
Splenic irradiation within 6 months prior to screening, or prior splenectomy.
Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy).
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function within 3 days prior to the first dose of study drug or during the study treatment period with the exception of low dose aspirin (up to 100 mg/day) and low-molecular-weight heparin.
Prior therapy with a BH3 mimetic compound or stem cell transplantation.
Participant has received strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin) or moderate CYP3A inhibitors (e.g., fluconazole) within 14 days prior to the administration of the first dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UAB Comprehensive Cancer Cente /ID# 165464
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35217
Country
United States
Facility Name
City of Hope /ID# 221395
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
St. Joseph Heritage Healthcare /ID# 230935
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Moore UC San Diego Cancer Center /ID# 164084
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Long Beach Memorial Medical Ct /ID# 230148
City
Long Beach
State/Province
California
ZIP/Postal Code
90806-1701
Country
United States
Facility Name
Universtiy of Southern California /ID# 164095
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ventura Oncology /ID# 230940
City
Oxnard
State/Province
California
ZIP/Postal Code
93030-3790
Country
United States
Facility Name
St Joseph Heritage Healthcare /ID# 230936
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Icri /Id# 222546
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Colorado Blood Cancer Institute /ID# 224250
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Associates /ID# 230918
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360-2700
Country
United States
Facility Name
Holy Cross Hospital /ID# 230922
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-8432
Country
United States
Facility Name
Mayo Clinic /ID# 164201
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer Specialists of North Florida /ID# 230917
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ocala Oncology Florida Cancer Affiliates /ID# 230927
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474-4445
Country
United States
Facility Name
Moffitt Cancer Center /ID# 164082
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
University Cancer & Blood Center /ID# 230939
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
University of Chicago Medicine /ID# 164115
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Carle Cancer Institute /ID# 230571
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801-1645
Country
United States
Facility Name
Fort Wayne Medical Oncology /ID# 230919
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Indiana Blood & Marrow Transpl /ID# 165075
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Health Network /ID# 230915
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250-2042
Country
United States
Facility Name
Memorial Hospital of South Bend /ID# 230912
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601-1033
Country
United States
Facility Name
Pontchartrain Cancer Center /ID# 230932
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-7512
Country
United States
Facility Name
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Frederick Health /ID# 230920
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702-4920
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 162675
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Southcoast Health Cancer Center /ID# 230934
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719-5208
Country
United States
Facility Name
University of Massachusetts Wo /ID# 222547
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital /ID# 162682
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension Providence Southfield Cancer Center /ID# 223876
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075-3707
Country
United States
Facility Name
Central Care Cancer Center /ID# 230913
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Capital Region Medical Center /ID# 232627
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65102
Country
United States
Facility Name
MidAmerica Division, Inc. /ID# 222058
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada /ID# 230916
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169-3321
Country
United States
Facility Name
New Jersey Cancer Care & Blood Disorders /ID# 230925
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109-3550
Country
United States
Facility Name
Summit Medical Group /ID# 230937
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932-1049
Country
United States
Facility Name
Weill Cornell Medical College /ID# 162679
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Southeastern Medical Oncology Center /ID# 230954
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University /ID# 217402
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1280
Country
United States
Facility Name
OhioHealth /ID# 230928
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Cancer Specialists /ID# 230929
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Bend Memorial Clinic /ID# 224184
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Oregon Oncology Specialists /ID# 230931
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301-3975
Country
United States
Facility Name
Gettysburg Cancer Center /ID# 230921
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
West Penn Hospital /ID# 222618
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1722
Country
United States
Facility Name
Medical University of South Carolina /ID# 222597
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St Francis Cancer Center /ID# 230254
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607-5253
Country
United States
Facility Name
Sanford Cancer Center /ID# 230933
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104-4663
Country
United States
Facility Name
Avera Cancer Institute /ID# 222364
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Prairie Lakes Healthcare System /ID# 224358
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 221410
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Texas Oncology - West Texas /ID# 224784
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Mary Crowley Cancer Research /ID# 230923
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
Oncology Consultants /ID# 230930
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3306
Country
United States
Facility Name
MD Anderson Cancer Center at Texas Medical Center /ID# 162683
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Facility Name
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Community Cancer Trials of Utah /ID# 230914
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405-7194
Country
United States
Facility Name
Utah Cancer Specialists Salt Lake Clinic /ID# 222806
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Utah /ID# 164116
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg /ID# 231372
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408-1949
Country
United States
Facility Name
Northwest Medical Specialties /ID# 230926
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
The Kinghorn Cancer Centre /ID# 214657
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Barwon Health /ID# 222430
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Peter MacCallum Cancer Ctr /ID# 218352
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Alfred Health /ID# 215545
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 216809
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
AZ Klina /ID# 230592
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
UMHAT Sveti Ivan Rilski /ID# 231163
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Sveta Marina /ID# 231411
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
University of Alberta Hospital - Division of Hematology /ID# 217698
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 214483
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital /ID# 217586
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Center Research Institute /ID# 223976
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Klinicka bolnica Dubrava Zagreb /ID# 230504
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica Merkur /ID# 230599
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 230602
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 230601
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Centre Hospitalier de CHAMBERY /ID# 230889
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
CHU de Nimes /ID# 230888
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
AP-HP - Hopital Necker /ID# 230900
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Saint Louis /ID# 230887
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
General Hospital of Athens Laiko /ID# 230394
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital Attikon /ID# 230395
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306
City
Budapest IX
State/Province
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 230518
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Hadassah Medical Center-Hebrew University /ID# 230310
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Assuta Ashdod Medical Center /ID# 230396
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Galilee Medical Center /ID# 230397
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 230311
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST Papa Giovanni XXIII /ID# 214900
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Spedali civili di Brescia /ID# 230420
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 214555
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
ASST Sette Laghi /ID# 214551
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Fujita Health University Hospital /ID# 221539
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Aomori Prefectural Central Hospital /ID# 221773
City
Aomori-shi
State/Province
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Kyushu University Hospital /ID# 222691
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Keiyukai Daini Hospital /ID# 222693
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
730-0035
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 222690
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital /ID# 222689
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center /ID# 222332
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Juntendo University Hospital /ID# 221484
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital /ID# 222692
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
University of Yamanashi Hospital /ID# 221700
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3821
Country
Japan
Facility Name
Seoul National University Hospital /ID# 230380
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 230381
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
ARS-MEDICAL Sp. z o.o. /ID# 230809
City
Pila
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Facility Name
VA Caribbean Healthcare System /ID# 222416
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
City Clinical Hospital named after S.P. Botkin /ID# 230508
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital /ID# 230507
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
University Clinical Center Serbia /ID# 230629
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 230681
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 230550
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 230525
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Hospital Universitario Central de Asturias /ID# 230884
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 214704
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Regional de Malaga /ID# 230858
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718
City
Pamplona
State/Province
Navarra, Comunidad
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 222415
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 231538
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 214676
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 214710
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 214709
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 230371
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 230372
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Ankara Universitesi Fakultesi /ID# 230317
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Adnan Menderes University /ID# 230777
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty /ID# 231321
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ondokuz mayis University Facul /ID# 230314
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Guy's and St Thomas' NHS Foundation Trust /ID# 164110
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Oxford Univ Hosp NHS Trust /ID# 214503
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust /ID# 216991
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
The Christie Hospital /ID# 164111
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Aneurin Bevan University Health Board /ID# 230332
City
Newport
ZIP/Postal Code
NP18 3XQ
Country
United Kingdom
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/
Citations:
PubMed Identifier
35576960
Citation
Pemmaraju N, Garcia JS, Potluri J, Harb JG, Sun Y, Jung P, Qin QQ, Tantravahi SK, Verstovsek S, Harrison C. Addition of navitoclax to ongoing ruxolitinib treatment in patients with myelofibrosis (REFINE): a post-hoc analysis of molecular biomarkers in a phase 2 study. Lancet Haematol. 2022 Jun;9(6):e434-e444. doi: 10.1016/S2352-3026(22)00116-8. Epub 2022 May 13.
Results Reference
derived
PubMed Identifier
35180010
Citation
Harrison CN, Garcia JS, Somervaille TCP, Foran JM, Verstovsek S, Jamieson C, Mesa R, Ritchie EK, Tantravahi SK, Vachhani P, O'Connell CL, Komrokji RS, Harb J, Hutti JE, Holes L, Masud AA, Nuthalapati S, Potluri J, Pemmaraju N. Addition of Navitoclax to Ongoing Ruxolitinib Therapy for Patients With Myelofibrosis With Progression or Suboptimal Response: Phase II Safety and Efficacy. J Clin Oncol. 2022 May 20;40(15):1671-1680. doi: 10.1200/JCO.21.02188. Epub 2022 Feb 18.
Results Reference
derived
Learn more about this trial
A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
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