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: Completed
• Conditions: Myelofibrosis (MF)
• Intervention / Treatment: Drug: Ruxolitinib; Drug: Navitoclax

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

Expanded Access

No longer 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
      • The Alfred Hospital /ID# 215545
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 216809
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Duplicate_University of Alberta Hospital - Division of Hematology /ID# 217698
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network_Princess Margaret Cancer Centre /ID# 214483
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center Research Institute /ID# 223976
• Croatia
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Clinical Hospital Dubrava /ID# 230504
    • Zagreb, City of Zagreb, Croatia, 10000
      • Klinicka bolnica Merkur /ID# 230599
    • Zagreb, City of Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 230602
  • Split-Dalmatia County
    • Split, Split-Dalmatia County, Croatia, 21000
      • Klinicki Bolnicki Centar (KBC) Split /ID# 230601
• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Laiko /ID# 230394
    • Athens, Attica, Greece, 12462
      • Duplicate_University General Hospital Attikon /ID# 230395
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 230518
  • Budapest, Hungary, 1097
    • Duplicate_Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 230306
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 230585
• Israel
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 230310
  • Northern District
    • Nahariya, Northern District, Israel, 2210001
      • Galilee Medical Center /ID# 230397
  • Southern District
    • Ashdod, Southern District, Israel, 7747629
      • Assuta Ashdod Medical Center /ID# 230396
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 230311
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII /ID# 214900
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia /ID# 230420
  • Catania, Italy, 95123
    • AOU Policlinico G. Rodolico - San Marco /ID# 214549
  • Reggio Calabria, Italy, 89125
    • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 230011
  • Varese, Italy, 21100
    • ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 214551
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 230012
  • Firenze
    • Florence, Firenze, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi /ID# 214555
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553
• Japan
  • Aichi-ken
    • Toyoake, Aichi-ken, Japan, 470-1192
      • Fujita Health University Hospital /ID# 221539
  • Aomori
    • Aomori, Aomori, Japan, 030-8553
      • Aomori Prefectural Central Hospital /ID# 221773
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 222691
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0006
      • Sapporo Hokuyu 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
      • Duplicate_Dokkyo Medical University Saitama Medical Center /ID# 222332
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 221484
    • Bunkyo-ku, Tokyo, Japan, 113-8602
      • Nippon Medical School Hospital /ID# 222692
  • Yamanashi
    • Chuo-shi, Yamanashi, Japan, 409-3821
      • University of Yamanashi Hospital /ID# 221700
• 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
• South Korea
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 230380
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 230381
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 222415
  • 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
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 214709
  • Málaga, Spain, 29011
    • Hospital Regional Universitario de Malaga /ID# 230858
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 214704
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 230372
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 230371
• 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
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 164110
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 214503
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35217
      • UAB Comprehensive Cancer Cente /ID# 165464
  • California
    • Cerritos, California, United States, 90703-2679
      • TOI Clinical Research /ID# 222546
    • Duarte, California, United States, 91010
      • City of Hope /ID# 221395
    • La Jolla, California, United States, 92093
      • Moores Cancer Center at UC San Diego /ID# 164084
    • Long Beach, California, United States, 90806-1701
      • Long Beach Memorial Medical Ct /ID# 230148
    • Los Angeles, California, United States, 90033
      • University of Southern California /ID# 164095
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute /ID# 224250
  • Florida
    • Jacksonville, Florida, United States, 32207-8432
      • Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 164201
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 164082
  • 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
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood & Marrow Transpl /ID# 165075
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Duplicate_American Oncology Partners of Maryland, PA /ID# 231299
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 162675
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts - Worcester /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
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Division, Inc. /ID# 222058
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College /ID# 162679
  • Ohio
    • Columbus, Ohio, United States, 43210-1280
      • The Ohio State University /ID# 217402
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic /ID# 224184
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224-1722
      • West Penn Hospital /ID# 222618
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Duplicate_Medical University of South Carolina /ID# 222597
  • South Dakota
    • 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, 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
    • 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

Participation Criteria

Eligibility Criteria

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

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 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navitoclax + ruxolitinib (Cohort 1a); Participants must have received ruxolitinib for at least 12 weeks and on stable dose of ≥10 mg tablets orally twice daily (BID) for ≥8 weeks prior to the 1st dose of navitoclax. Navitoclax tablets are administered once daily (QD) at a starting dose of 50 mg. This was increased after approximately ≥7 days to next dose level if platelet count is ≥75 × 10^9/L up to a maximum dose of navitoclax 300 mg QD. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first).	Drug: Ruxolitinib; Tablet; Oral; Other Names: Jakafi; Drug: Navitoclax; Film-coated tablet; Oral; Other Names: ABT-263
Experimental: Navitoclax + ruxolitinib (Cohort 1b); Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first).	Drug: Ruxolitinib; Tablet; Oral; Other Names: Jakafi; Drug: Navitoclax; Film-coated tablet; Oral; Other Names: ABT-263
Experimental: Navitoclax (Cohort 2); Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first).	Drug: Navitoclax; Film-coated tablet; Oral; Other Names: ABT-263
Experimental: Navitoclax + ruxolitinib (Cohort 3); Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first).	Drug: Ruxolitinib; Tablet; Oral; Other Names: Jakafi; Drug: Navitoclax; Film-coated tablet; Oral; Other Names: ABT-263

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24	Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24	TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0. Participants complete a symptom diary and rate the following seven MF symptoms: fatigue, night sweats, abdominal discomfort, pruritus, pain under the ribs on the left side, early satiety, and bone pain daily using a scale from 0 (absent) to 10 (worst imaginable), and the scores are averaged over 7 days, with a minimum of 4 days required to calculate the average score. Participants for whom a valid average score cannot be calculated either at baseline or post-baseline are considered non-responders. The TSS reflects the sum of the scores of these symptoms, for a maximum possible score of 70 (i.e., most severe symptom experience).	Baseline, Week 24
Percentage of Participants Achieving Anemia Response	For a participant who is transfusion independent (TI) at Baseline with hemoglobin value < 10 g/dL, anemia response is achieved if the post-Baseline hemoglobin level increases by ≥2 g/dL without receiving packed red blood cells (PRBC) transfusion (for any reason) within 2 weeks and without any erythropoietin or mimetics within the last 4 weeks prior to the increase in hemoglobin level by ≥2g/dL was observed. Hemoglobin values more than 30 days after the last dose of study treatment or after the start of post-study treatment or disease progression, whichever is earlier, will not be considered in the analysis of anemia response. For a participant who is transfusion dependent (TD) at Baseline, anemia response is defined as a period of at least 12 consecutive weeks without PRBC transfusion at any time after the first dose of study drug and on or prior to 30 days post last dose of study drug, the start of post-study treatment, disease progression or death, whichever occurs earlier.	Up to 254 weeks
Percentage of Participants With ≥ 1 Grade Reduction From Baseline in Fibrosis Grade At Any Time	Bone marrow grading is assessed according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.	Up to 254 weeks
Time to First Reduction in Fibrosis Grade	Grade of bone marrow fibrosis was assessed by investigators according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. The time to first achieving a reduction of at least 1 grade in bone marrow fibrosis from Baseline was summarized.	Up to 254 weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., 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.
• Pemmaraju N, Somervaille TCP, Palandri F, Harrison C, Komrokji RS, Perkins A, Ayala Diaz RM, Lavie D, Tomita A, Feng Y, Qin Q, Harb J, Polepally AR, Potluri J, Garcia JS. Addition of navitoclax to ruxolitinib for patients with myelofibrosis with progression or suboptimal response. Blood Neoplasia. 2024 Nov 2;2(1):100056. doi: 10.1016/j.bneo.2024.100056. eCollection 2025 Feb.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): January 29, 2025

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 (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

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: Pathological Conditions, Anatomical; Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hypertrophy; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Primary Myelofibrosis; Splenomegaly; Antineoplastic Agents; ruxolitinib; 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