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

December 29, 2025 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24
Time Frame: Baseline, Week 24
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24
Time Frame: Baseline, 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
Time Frame: Up to 254 weeks

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
Time Frame: Up to 254 weeks
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
Time Frame: Up to 254 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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