A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis (REFINE)

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelofibrosis (MF)
• Intervention / Treatment: Drug: Ruxolitinib; Drug: Navitoclax

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • The Kinghorn Cancer Centre /ID# 214657
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Health /ID# 222430
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Ctr /ID# 218352
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health /ID# 215545
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 216809
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ Klina /ID# 230592
• Bulgaria
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 231163
  • Varna, Bulgaria, 9010
    • UMHAT Sveta Marina /ID# 231411
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital - Division of Hematology /ID# 217698
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre /ID# 214483
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 217586
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center Research Institute /ID# 223976
• Croatia
  • Split, Croatia, 21000
    • Klinicki bolnicki centar Split /ID# 230601
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicka bolnica Dubrava Zagreb /ID# 230504
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicka bolnica Merkur /ID# 230599
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 230602
• France
  • Chambery, France, 73000
    • Centre Hospitalier de CHAMBERY /ID# 230889
  • Nimes, France, 30029
    • CHU de Nimes /ID# 230888
  • Paris, France, 75015
    • AP-HP - Hopital Necker /ID# 230900
  • Paris, France, 75475
    • Hopital Saint Louis /ID# 230887
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Laiko /ID# 230394
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 230395
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 230518
  • Nyiregyhaza, Hungary, 4400
    • Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585
  • Budapest
    • Budapest IX, Budapest, Hungary, 1097
      • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306
• Israel
  • Ashdod, Israel, 7747629
    • Assuta Ashdod Medical Center /ID# 230396
  • Nahariya, Israel, 2210001
    • Galilee Medical Center /ID# 230397
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center /ID# 230311
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 9112001
      • Hadassah Medical Center-Hebrew University /ID# 230310
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII /ID# 214900
  • Bologna, Italy, 40138
    • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012
  • Brescia, Italy, 25123
    • ASST Spedali civili di Brescia /ID# 230420
  • Catania, Italy, 95123
    • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549
  • Florence, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi /ID# 214555
  • Reggio Calabria, Italy, 89124
    • Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011
  • Varese, Italy, 21100
    • ASST Sette Laghi /ID# 214551
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553
• Japan
  • Aichi
    • Toyoake-shi, Aichi, Japan, 470-1192
      • Fujita Health University Hospital /ID# 221539
  • Aomori
    • Aomori-shi, Aomori, Japan, 030-8553
      • Aomori Prefectural Central Hospital /ID# 221773
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 222691
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 730-0035
      • Keiyukai Daini Hospital /ID# 222693
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 222690
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 222689
  • Saitama
    • Koshigaya-shi, Saitama, Japan, 343-8555
      • Dokkyo Medical University Saitama Medical Center /ID# 222332
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 221484
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital /ID# 222692
  • Yamanashi
    • Chuo-shi, Yamanashi, Japan, 409-3821
      • University of Yamanashi Hospital /ID# 221700
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 230380
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 230381
• Poland
  • Wielkopolskie
    • Pila, Wielkopolskie, Poland, 64-920
      • ARS-MEDICAL Sp. z o.o. /ID# 230809
• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
    • VA Caribbean Healthcare System /ID# 222416
  • San Juan, Puerto Rico, 00927
    • Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544
• Russian Federation
  • Moscow, Russian Federation, 125284
    • City Clinical Hospital named after S.P. Botkin /ID# 230508
  • Saint Petersburg, Russian Federation, 194291
    • Leningrad Regional Clinical Hospital /ID# 230507
  • Saint Petersburg, Russian Federation, 197341
    • Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506
• Serbia
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • University Clinical Center Serbia /ID# 230629
    • Belgrade, Beograd, Serbia, 11080
      • Clin Hosp Ctr Bezanijska Kosa /ID# 230681
  • Sumadijski Okrug
    • Kragujevac, Sumadijski Okrug, Serbia, 34000
      • University Clinical Center Kragujevac /ID# 230550
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Clinical Center Vojvodina /ID# 230525
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 222415
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 231538
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 214676
  • Madrid, Spain, 28027
    • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 214710
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 214709
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias /ID# 230884
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 214704
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Hospital Regional de Malaga /ID# 230858
  • Navarra, Comunidad
    • Pamplona, Navarra, Comunidad, Spain, 31008
      • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital /ID# 230371
  • Tainan City, Taiwan, 70403
    • National Cheng Kung University Hospital /ID# 230372
• Turkey
  • Ankara, Turkey, 06620
    • Ankara Universitesi Fakultesi /ID# 230317
  • Aydin, Turkey, 09100
    • Adnan Menderes University /ID# 230777
  • Istanbul, Turkey, 34098
    • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medical Faculty /ID# 231321
  • Samsun, Turkey, 55200
    • Ondokuz mayis University Facul /ID# 230314
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast Health and Social Care Trust /ID# 216991
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital /ID# 164111
  • Newport, United Kingdom, NP18 3XQ
    • Aneurin Bevan University Health Board /ID# 230332
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Foundation Trust /ID# 164110
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Oxford Univ Hosp NHS Trust /ID# 214503
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35217
      • UAB Comprehensive Cancer Cente /ID# 165464
  • California
    • Duarte, California, United States, 91010
      • City of Hope /ID# 221395
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare /ID# 230935
    • La Jolla, California, United States, 92093
      • Moore UC San Diego Cancer Center /ID# 164084
    • Long Beach, California, United States, 90806-1701
      • Long Beach Memorial Medical Ct /ID# 230148
    • Los Angeles, California, United States, 90033
      • Universtiy of Southern California /ID# 164095
    • Oxnard, California, United States, 93030-3790
      • Ventura Oncology /ID# 230940
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare /ID# 230936
    • Whittier, California, United States, 90603
      • Icri /Id# 222546
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute /ID# 224250
  • Connecticut
    • Norwich, Connecticut, United States, 06360-2700
      • Eastern Connecticut Hematology and Oncology Associates /ID# 230918
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 230922
    • Jacksonville, Florida, United States, 32207-8432
      • Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 164201
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida /ID# 230917
    • Ocala, Florida, United States, 34474-4445
      • Ocala Oncology Florida Cancer Affiliates /ID# 230927
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 164082
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer & Blood Center /ID# 230939
  • Illinois
    • Chicago, Illinois, United States, 60637-1426
      • University of Chicago Medicine /ID# 164115
    • Normal, Illinois, United States, 61761
      • Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536
    • Urbana, Illinois, United States, 61801-1645
      • Carle Cancer Institute /ID# 230571
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology /ID# 230919
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood & Marrow Transpl /ID# 165075
    • Indianapolis, Indiana, United States, 46250-2042
      • Community Health Network /ID# 230915
    • South Bend, Indiana, United States, 46601-1033
      • Memorial Hospital of South Bend /ID# 230912
  • Louisiana
    • Covington, Louisiana, United States, 70433-7512
      • Pontchartrain Cancer Center /ID# 230932
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299
    • Frederick, Maryland, United States, 21702-4920
      • Frederick Health /ID# 230920
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 162675
    • Fairhaven, Massachusetts, United States, 02719-5208
      • Southcoast Health Cancer Center /ID# 230934
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Wo /ID# 222547
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital /ID# 162682
    • Southfield, Michigan, United States, 48075-3707
      • Ascension Providence Southfield Cancer Center /ID# 223876
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center /ID# 230913
    • Jefferson City, Missouri, United States, 65102
      • Capital Region Medical Center /ID# 232627
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Division, Inc. /ID# 222058
    • Saint Joseph, Missouri, United States, 64507
      • Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924
  • Nevada
    • Las Vegas, Nevada, United States, 89169-3321
      • Comprehensive Cancer Centers of Nevada /ID# 230916
  • New Jersey
    • Belleville, New Jersey, United States, 07109-3550
      • New Jersey Cancer Care & Blood Disorders /ID# 230925
    • Florham Park, New Jersey, United States, 07932-1049
      • Summit Medical Group /ID# 230937
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College /ID# 162679
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center /ID# 230954
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938
    • Columbus, Ohio, United States, 43210-1280
      • The Ohio State University /ID# 217402
    • Columbus, Ohio, United States, 43214
      • OhioHealth /ID# 230928
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists /ID# 230929
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic /ID# 224184
    • Salem, Oregon, United States, 97301-3975
      • Oregon Oncology Specialists /ID# 230931
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center /ID# 230921
    • Pittsburgh, Pennsylvania, United States, 15224-1722
      • West Penn Hospital /ID# 222618
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 222597
    • Greenville, South Carolina, United States, 29607-5253
      • St Francis Cancer Center /ID# 230254
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104-4663
      • Sanford Cancer Center /ID# 230933
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute /ID# 222364
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Healthcare System /ID# 224358
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 221410
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Oncology - West Texas /ID# 224784
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research /ID# 230923
    • Dallas, Texas, United States, 75246-2003
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159
    • Houston, Texas, United States, 77030-3306
      • Oncology Consultants /ID# 230930
    • Houston, Texas, United States, 77030-4000
      • MD Anderson Cancer Center at Texas Medical Center /ID# 162683
    • San Antonio, Texas, United States, 78229
      • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094
  • Utah
    • Ogden, Utah, United States, 84405-7194
      • Community Cancer Trials of Utah /ID# 230914
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists Salt Lake Clinic /ID# 222806
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 164116
  • Virginia
    • Fredericksburg, Virginia, United States, 22408-1949
      • Hematology Oncology Associates of Fredericksburg /ID# 231372
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties /ID# 230926

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navitoclax + ruxolitinib; 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).	Drug: Ruxolitinib; Tablet; Oral; Other Names: Jakafi; Drug: Navitoclax; Tablet; Oral; Other Names: ABT-263
Experimental: Navitoclax; Participants will be administered various doses of navitoclax once daily (QD)	Drug: Navitoclax; Tablet; Oral; Other Names: ABT-263

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From Baseline (Week 0) through Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving 50% Reduction in Total System Score (TSS)	TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.	From Baseline (Week 0) through Week 24
Anemia Response	The anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.	Every 12 weeks up to approximately 96 weeks
Change in Grade of Bone Marrow Fibrosis	Bone marrow grading is assessed according to the European Consensus Grading System.	Through Week 96

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): March 28, 2022
• Study Completion (Anticipated): February 2, 2029

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Primary Myelofibrosis; splenomegaly; ruxolitinib; Post-polycythemia vera MF (PPV-MF); Post-essential thrombocythemia (PET-MF); navitoclax; splenic volume; Jakafi; enlarged spleen; ABT 263; bone marrow fibrosis
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Primary Myelofibrosis; Antineoplastic Agents; Navitoclax
• Other Study ID Numbers: M16-109; 2017-001398-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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