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Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis (TRANSFORM-1)

Primary Purpose

Myelofibrosis (MF)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Navitoclax
Ruxolitinib
Placebo for Navitoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis (MF) focused on measuring Myelofibrosis, Navitoclax, Ruxolitinib, Cancer, ABT-263, TRANSFORM-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) .
  • Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days prior to randomization.

    -- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.

  • Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
  • Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
  • Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

  • Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
  • Prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
  • 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 milligram daily) and low molecular weight heparin (LMWH).

Sites / Locations

  • Highlands Oncology Group, PA /ID# 221824
  • Providence Medical Foundation /ID# 241646
  • Moores Cancer Center at UC San Diego /ID# 218012
  • Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562
  • Lynn Cancer Institute, Boca /ID# 230687
  • Florida Cancer Specialist - South /ID# 221726
  • Florida Cancer Specialists - North /ID# 221727
  • Florida Cancer Specialists - East /ID# 221728
  • Emory University /ID# 221562
  • Augusta University Georgia Cancer Center /ID# 221551
  • Columbus Regional Research Institute /ID# 227272
  • Rush University Medical Center /ID# 221581
  • Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
  • Indiana Blood & Marrow Transpl /ID# 221586
  • University of Kansas Cancer Center /ID# 218144
  • Massachusetts General Hospital /ID# 221559
  • Beth Israel Deaconess Medical Center /ID# 224261
  • Dana-Farber Cancer Institute /ID# 218010
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658
  • Minnesota Oncology Hematology /ID# 227357
  • MidAmerica Division, Inc. /ID# 221743
  • Hackensack Univ Med Ctr /ID# 221654
  • Northwell Health - Monter Cancer Center /ID# 222996
  • Weill Cornell Medical College /ID# 220933
  • Gabrail Cancer Center Research /ID# 230488
  • Oncology Hematology Care, Inc. /ID# 222556
  • The Ohio State University /ID# 221584
  • UPMC Hillman Cancer Ctr /ID# 218134
  • Thompson Cancer Survival Ctr /ID# 231689
  • University of Texas MD Anderson Cancer Center /ID# 217994
  • Texas Oncology - Northeast Texas /ID# 241813
  • Utah Cancer Specialists Salt Lake Clinic /ID# 221961
  • University of Utah /ID# 221009
  • Virginia Cancer Specialists - Fairfax /ID# 242682
  • VA Puget Sound Health Care System /ID# 231691
  • The Kinghorn Cancer Centre /ID# 221503
  • Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311
  • Gosford Hospital /ID# 221499
  • Liverpool Hospital /ID# 221803
  • Townsville University Hospital /ID# 229794
  • Peter MacCallum Cancer Ctr /ID# 229795
  • Alfred Health /ID# 221501
  • Royal Perth Hospital /ID# 223203
  • Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
  • Klinikum Wels-Grieskirchen GmbH /ID# 220901
  • Medizinische Universitaet Graz /ID# 220910
  • Medizinische Universitaet Wien /ID# 220906
  • Hanusch Krankenhaus /ID# 220909
  • CHU UCL Namur - site Godinne /ID# 221127
  • UZ Gent /ID# 221125
  • Universitair Ziekenhuis Leuven /ID# 218806
  • AZ-Delta /ID# 221466
  • ZNA Stuivenberg /ID# 221465
  • AZ Sint-Jan Brugge /ID# 218805
  • Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874
  • Vitaz /Id# 229861
  • UMHAT Alexandrovska EAD /ID# 231056
  • UMHAT Dr Georgi Stranski EAD /ID# 231161
  • UMHAT Sveti Georgi /ID# 231053
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036
  • UMHAT Sveti Ivan Rilski /ID# 231028
  • Royal Victoria Hospital /ID# 222636
  • Juravinski Cancer Centre /ID# 221752
  • Lakeridge Health - Oshawa /ID# 222080
  • Niagara Health System /ID# 230994
  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
  • Clinical Hospital Dubrava /ID# 230795
  • Klinicka bolnica Merkur /ID# 231155
  • Klinicki bolnicki centar Zagreb /ID# 230793
  • Klinicki bolnicki centar Split /ID# 230796
  • HCL - Hopital Lyon Sud /ID# 222913
  • CHU NIMES - Hopital Caremeau /ID# 219114
  • CHU Bordeaux - Hopital Haut Leveque /ID# 222518
  • CH Roubaix - Hopital Victor Provo /ID# 219116
  • Hopital Avicenne - APHP /ID# 221286
  • CHU de Nantes, Hotel Dieu -HME /ID# 219113
  • Centre Hospitalier de CHAMBERY /ID# 224506
  • Chu Angers /Id# 219115
  • AP-HP - Hopital Saint-Louis /ID# 221288
  • AP-HP - Hopital Necker /ID# 231318
  • ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978
  • Universitatsklinikum Mannheim /ID# 221523
  • Haemato-Onkologie /ID# 221061
  • Universitaetsklinikum Aachen /ID# 221519
  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
  • Universitaetsklinikum Essen /ID# 221522
  • OncoResearch Lerchenfeld GmbH /ID# 230867
  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520
  • General Hospital of Athens Laiko /ID# 230785
  • University General Hospital Attikon /ID# 230784
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
  • The Chaim Sheba Medical Center /ID# 219137
  • Tel Aviv Sourasky Medical Center /ID# 219134
  • Hadassah Medical Center-Hebrew University /ID# 219110
  • Assaf Harofeh Medical Center /ID# 222957
  • Rambam Health Care Campus /ID# 219120
  • Meir Medical Center /ID# 221374
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867
  • ASST Spedali civili di Brescia /ID# 241273
  • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085
  • Azienda Ospedaliero Universitaria Careggi /ID# 219086
  • ASST Sette Laghi /ID# 219084
  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100
  • Fujita Health University Hospital /ID# 221537
  • Chiba University Hospital /ID# 239345
  • National Cancer Center Hospital East /ID# 226093
  • Ehime University Hospital /ID# 221443
  • Kyushu University Hospital /ID# 221783
  • Fukushima Medical University Hospital /ID# 222752
  • Ogaki Municipal Hospital /ID# 240173
  • Gunmaken Saiseikai Maebashi Hospital /ID# 242806
  • Gunma University Hospital /ID# 221480
  • Hokkaido University Hospital /ID# 242667
  • Kobe University Hospital /ID# 246236
  • Hitachi General Hospital /ID# 240048
  • Kanazawa University Hospital /ID# 238424
  • Medical Corporation Seijinkai Ikeda Hospital /ID# 242172
  • Kyoto University Hospital /ID# 238423
  • Mie University Hospital /ID# 221664
  • University of Miyazaki Hospital /ID# 221483
  • Kawasaki Medical School Hospital /ID# 221481
  • Kurashiki Central Hospital /ID# 221692
  • Kansai Medical University Hospital /ID# 221482
  • Kindai University Hospital /ID# 221479
  • Osaka University Hospital /ID# 221478
  • Dokkyo Medical University Saitama Medical Center /ID# 222333
  • Juntendo University Shizuoka Hospital /ID# 221782
  • Juntendo University Hospital /ID# 221405
  • Nippon Medical School Hospital /ID# 221674
  • University of Yamanashi Hospital /ID# 221701
  • Seoul National University Bundang Hospital /ID# 219053
  • Inje University Busan Paik Hospital /ID# 231667
  • Pusan National University Hospital /ID# 222087
  • Kyungpook National University Hospital /ID# 231666
  • Gachon University Gil Medical Center /ID# 222089
  • Seoul National University Hospital /ID# 219055
  • Asan Medical Center /ID# 219054
  • Samsung Medical Center /ID# 221068
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056
  • Radboud Universitair Medisch Centrum /ID# 218948
  • Albert Schweitzer Ziekenhuis /ID# 224015
  • Universitair Medisch Centrum Groningen /ID# 218947
  • Universitair Medisch Centrum Utrecht /ID# 218949
  • Middlemore Clinical Trials /ID# 230770
  • Moscow State budget healthcare /ID# 221025
  • Clinic UZI 4D /ID# 221024
  • Republican hospital named after V.A. Baranov /ID# 221412
  • Leningrad Regional Clinical Hospital /ID# 221028
  • Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029
  • Almazov National Medical Research Centre /ID# 221033
  • Tula Regional Clinical Hospital /ID# 221027
  • University Clinical Center Serbia /ID# 230854
  • Clin Hosp Ctr Bezanijska Kosa /ID# 230946
  • University Clinical Center Kragujevac /ID# 230855
  • Clinical Center Vojvodina /ID# 230853
  • Wits Clinical Research Site /ID# 232071
  • Wits Clinical Research Site /ID# 232072
  • Albert Alberts Stem Cell Transplant Centre /ID# 232073
  • Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
  • Hospital Universitario Germans Trias i Pujol /ID# 229936
  • Hospital Universitario Dr. Negrin /ID# 220897
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720
  • Hospital Parc de Salut del Mar /ID# 220913
  • Hospital Universitario Vall d'Hebron /ID# 229690
  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
  • Hospital Universitario Ramon y Cajal /ID# 220877
  • Hospital Universitario 12 de Octubre /ID# 229691
  • Hospital Universitario Virgen de la Victoria /ID# 220878
  • Hospital Clinico Universitario de Valencia /ID# 220875
  • Orebro Universitetssjukhuset /ID# 220829
  • Skane University Hospital Lund /ID# 220835
  • Sahlgrenska University Hospital /ID# 218776
  • Kaohsiung Chang Gung Memorial Hospital /ID# 218984
  • China Medical University Hospital /ID# 218978
  • Chi Mei Hospital - Liouying /ID# 221145
  • National Taiwan University Hospital /ID# 218976
  • Taipei Veterans General Hosp /ID# 221146
  • Linkou Chang Gung Memorial Hospital /ID# 218983
  • Hacettepe University Medical Faculty /ID# 230759
  • Trakya University Medical Facu /ID# 230754
  • Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
  • Ege University Medical Faculty /ID# 230753
  • Inonu University Medical Faculty /ID# 230758
  • Communal non-profit enterprise Regional Center of Oncology /ID# 230832
  • Medical Center "OK!Clinic+" /ID# 230834
  • Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370
  • SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833
  • United Lincolnshire Hospitals NHS Trust /ID# 231471
  • Guys and St Thomas NHS Foundation Trust /ID# 219185
  • Oxford University Hospitals NHS Foundation Trust /ID# 219192
  • University Hospitals Birmingham NHS Foundation Trust /ID# 221333
  • The Christie Hospital /ID# 219191

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navitoclax + Ruxolitinib

Placebo for Navitoclax + Ruxolitinib

Arm Description

Participants will receive Navitoclax in combination with Ruxolitinib

Participants will receive placebo for Navitoclax and Ruxolitinib

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

Change 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% (SVR35)
Reduction in spleen volume is measured by MRI or CT, per IWG criteria.
Duration of 35% Spleen Volume Reduction (SVR35)
Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).
Change In Fatigue
Change in fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 7a.
Change in Physical Functioning
Change in 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 who achieve Anemia Response
The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.
Leukemia-Free Survival
Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.
Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis
Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.

Full Information

First Posted
July 14, 2020
Last Updated
April 26, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04472598
Brief Title
Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
Acronym
TRANSFORM-1
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
October 19, 2032 (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
Yes

5. Study Description

Brief Summary
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, 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
Myelofibrosis, Navitoclax, Ruxolitinib, Cancer, ABT-263, TRANSFORM-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navitoclax + Ruxolitinib
Arm Type
Experimental
Arm Description
Participants will receive Navitoclax in combination with Ruxolitinib
Arm Title
Placebo for Navitoclax + Ruxolitinib
Arm Type
Active Comparator
Arm Description
Participants will receive placebo for Navitoclax and Ruxolitinib
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)
Placebo for Navitoclax
Intervention Description
Tablet; Oral
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
Change 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% (SVR35)
Description
Reduction in spleen volume is measured by MRI or CT, per IWG criteria.
Time Frame
Baseline (Week 0) Up to Week 96
Title
Duration of 35% Spleen Volume Reduction (SVR35)
Description
Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).
Time Frame
Baseline (Week 0) Up to Week 96
Title
Change In Fatigue
Description
Change in fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 7a.
Time Frame
Baseline (Week 0) Up to Week 24
Title
Change in Physical Functioning
Description
Change in 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 24
Title
Percentage of Participants who achieve Anemia Response
Description
The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
Time Frame
Baseline (Week 0) Up to Week 96
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Up To approximately 8 Years
Title
Leukemia-Free Survival
Description
Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.
Time Frame
Up To approximately 8 Years
Title
Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis
Description
Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.
Time Frame
Baseline (Week 0) Up to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) . Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization. -- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0. Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+). Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor. Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant. 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 milligram daily) and low molecular weight heparin (LMWH).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group, PA /ID# 221824
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Providence Medical Foundation /ID# 241646
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Moores Cancer Center at UC San Diego /ID# 218012
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Lynn Cancer Institute, Boca /ID# 230687
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Cancer Specialist - South /ID# 221726
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8108
Country
United States
Facility Name
Florida Cancer Specialists - North /ID# 221727
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705-1449
Country
United States
Facility Name
Florida Cancer Specialists - East /ID# 221728
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Emory University /ID# 221562
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Augusta University Georgia Cancer Center /ID# 221551
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-0003
Country
United States
Facility Name
Columbus Regional Research Institute /ID# 227272
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8915
Country
United States
Facility Name
Rush University Medical Center /ID# 221581
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Indiana Blood & Marrow Transpl /ID# 221586
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas Cancer Center /ID# 218144
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205-2528
Country
United States
Facility Name
Massachusetts General Hospital /ID# 221559
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 224261
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 218010
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnesota Oncology Hematology /ID# 227357
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
MidAmerica Division, Inc. /ID# 221743
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Hackensack Univ Med Ctr /ID# 221654
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Northwell Health - Monter Cancer Center /ID# 222996
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Weill Cornell Medical College /ID# 220933
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 230488
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oncology Hematology Care, Inc. /ID# 222556
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-2725
Country
United States
Facility Name
The Ohio State University /ID# 221584
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UPMC Hillman Cancer Ctr /ID# 218134
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Thompson Cancer Survival Ctr /ID# 231689
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 217994
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Northeast Texas /ID# 241813
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Utah Cancer Specialists Salt Lake Clinic /ID# 221961
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Utah /ID# 221009
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Virginia Cancer Specialists - Fairfax /ID# 242682
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
VA Puget Sound Health Care System /ID# 231691
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Facility Name
The Kinghorn Cancer Centre /ID# 221503
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311
City
East Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Gosford Hospital /ID# 221499
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Liverpool Hospital /ID# 221803
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Townsville University Hospital /ID# 229794
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Peter MacCallum Cancer Ctr /ID# 229795
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Alfred Health /ID# 221501
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital /ID# 223203
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH /ID# 220901
City
Wels
State/Province
Oberoesterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Medizinische Universitaet Graz /ID# 220910
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8010
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 220906
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch Krankenhaus /ID# 220909
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU UCL Namur - site Godinne /ID# 221127
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent /ID# 221125
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 218806
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ-Delta /ID# 221466
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
ZNA Stuivenberg /ID# 221465
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint-Jan Brugge /ID# 218805
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Vitaz /Id# 229861
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
UMHAT Alexandrovska EAD /ID# 231056
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 231161
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Sveti Georgi /ID# 231053
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 231028
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Royal Victoria Hospital /ID# 222636
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Juravinski Cancer Centre /ID# 221752
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Lakeridge Health - Oshawa /ID# 222080
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Niagara Health System /ID# 230994
City
St Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Clinical Hospital Dubrava /ID# 230795
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica Merkur /ID# 231155
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 230793
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 230796
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
HCL - Hopital Lyon Sud /ID# 222913
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU NIMES - Hopital Caremeau /ID# 219114
City
Nimes CEDEX 9
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 222518
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CH Roubaix - Hopital Victor Provo /ID# 219116
City
Roubaix Cedex 1
State/Province
Hauts-de-France
ZIP/Postal Code
59100
Country
France
Facility Name
Hopital Avicenne - APHP /ID# 221286
City
Bobigny
State/Province
Ile-de-France
ZIP/Postal Code
93000
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 219113
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier de CHAMBERY /ID# 224506
City
Chambery
State/Province
Savoie
ZIP/Postal Code
73000
Country
France
Facility Name
Chu Angers /Id# 219115
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
AP-HP - Hopital Saint-Louis /ID# 221288
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
AP-HP - Hopital Necker /ID# 231318
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978
City
Strasbourg Cedex
ZIP/Postal Code
67033
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 221523
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Haemato-Onkologie /ID# 221061
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
Universitaetsklinikum Aachen /ID# 221519
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Essen /ID# 221522
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
OncoResearch Lerchenfeld GmbH /ID# 230867
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
General Hospital of Athens Laiko /ID# 230785
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital Attikon /ID# 230784
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
The Chaim Sheba Medical Center /ID# 219137
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 219134
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 219110
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 222957
City
Be'Er Ya'Akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 219120
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center /ID# 221374
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Spedali civili di Brescia /ID# 241273
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 219086
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
ASST Sette Laghi /ID# 219084
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Fujita Health University Hospital /ID# 221537
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Chiba University Hospital /ID# 239345
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Cancer Center Hospital East /ID# 226093
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Ehime University Hospital /ID# 221443
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kyushu University Hospital /ID# 221783
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University Hospital /ID# 222752
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Ogaki Municipal Hospital /ID# 240173
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Gunmaken Saiseikai Maebashi Hospital /ID# 242806
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
Gunma University Hospital /ID# 221480
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 242667
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe University Hospital /ID# 246236
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Hitachi General Hospital /ID# 240048
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 238424
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Medical Corporation Seijinkai Ikeda Hospital /ID# 242172
City
Kanoya-shi
State/Province
Kagoshima
ZIP/Postal Code
893-0024
Country
Japan
Facility Name
Kyoto University Hospital /ID# 238423
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Mie University Hospital /ID# 221664
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
University of Miyazaki Hospital /ID# 221483
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Kawasaki Medical School Hospital /ID# 221481
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Kurashiki Central Hospital /ID# 221692
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 221482
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital /ID# 221479
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital /ID# 221478
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center /ID# 222333
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital /ID# 221782
City
Izunokuni-shi
State/Province
Shizuoka
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Juntendo University Hospital /ID# 221405
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital /ID# 221674
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8602
Country
Japan
Facility Name
University of Yamanashi Hospital /ID# 221701
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3821
Country
Japan
Facility Name
Seoul National University Bundang Hospital /ID# 219053
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital /ID# 231667
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 222087
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital /ID# 231666
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center /ID# 222089
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 219055
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 219054
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 221068
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Radboud Universitair Medisch Centrum /ID# 218948
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis /ID# 224015
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 218947
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 218949
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Middlemore Clinical Trials /ID# 230770
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Moscow State budget healthcare /ID# 221025
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Clinic UZI 4D /ID# 221024
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Republican hospital named after V.A. Baranov /ID# 221412
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital /ID# 221028
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029
City
Sankt-Peterburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre /ID# 221033
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Tula Regional Clinical Hospital /ID# 221027
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
University Clinical Center Serbia /ID# 230854
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 230946
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 230855
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 230853
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Wits Clinical Research Site /ID# 232071
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 232072
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Albert Alberts Stem Cell Transplant Centre /ID# 232073
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 229936
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Dr. Negrin /ID# 220897
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 220913
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 229690
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 220877
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 229691
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 220878
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 220875
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Orebro Universitetssjukhuset /ID# 220829
City
Orebro
State/Province
Orebro Lan
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Skane University Hospital Lund /ID# 220835
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
SE 221 41
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 218776
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 218984
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 218978
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi Mei Hospital - Liouying /ID# 221145
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 218976
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 221146
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 218983
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty /ID# 230759
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Trakya University Medical Facu /ID# 230754
City
Edirne, Istanbul
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Ege University Medical Faculty /ID# 230753
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Inonu University Medical Faculty /ID# 230758
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Communal non-profit enterprise Regional Center of Oncology /ID# 230832
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Medical Center "OK!Clinic+" /ID# 230834
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370
City
Kyiv
ZIP/Postal Code
03143
Country
Ukraine
Facility Name
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
United Lincolnshire Hospitals NHS Trust /ID# 231471
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN2 4AX
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 219185
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 219192
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 221333
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Christie Hospital /ID# 219191
City
Manchester
ZIP/Postal Code
M20 4BX
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/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M16-191
Description
Related Info

Learn more about this trial

Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

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