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Myelofibrosis (MF)Phase 2REFINENCT03222609

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

A Phase 2 study testing Ruxolitinib and Navitoclax in people with Myelofibrosis (MF), run by AbbVie at 91 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis (MF)
What is being tested?
Ruxolitinib and Navitoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
91 sitesin 14 countries
Study dates
31 Oct 2017to 29 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 14 countries.

91 sites in 14 countries

United States33 sites

  • Texas Oncology - West Texas /ID# 224784

    Abilene, Texas, 79606

  • Bend Memorial Clinic /ID# 224184

    Bend, Oregon, 97701

  • Duplicate_American Oncology Partners of Maryland, PA /ID# 231299

    Bethesda, Maryland, 20817

  • UAB Comprehensive Cancer Cente /ID# 165464

    Birmingham, Alabama, 35217

  • Dana-Farber Cancer Institute /ID# 162675

    Boston, Massachusetts, 02215

  • TOI Clinical Research /ID# 222546

    Cerritos, California, 90703-2679

  • Duplicate_Medical University of South Carolina /ID# 222597

    Charleston, South Carolina, 29425

  • University of Chicago Medicine /ID# 164115

    Chicago, Illinois, 60637-1426

  • The Ohio State University /ID# 217402

    Columbus, Ohio, 43210-1280

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159

    Dallas, Texas, 75246-2003

  • Colorado Blood Cancer Institute /ID# 224250

    Denver, Colorado, 80218

  • Henry Ford Hospital /ID# 162682

    Detroit, Michigan, 48202

  • City of Hope /ID# 221395

    Duarte, California, 91010

  • Oncology Consultants /ID# 230930

    Houston, Texas, 77030-3306

  • MD Anderson Cancer Center at Texas Medical Center /ID# 162683

    Houston, Texas, 77030-4000

  • Indiana Blood & Marrow Transpl /ID# 165075

    Indianapolis, Indiana, 46237

  • Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548

    Jacksonville, Florida, 32207-8432

  • Mayo Clinic /ID# 164201

    Jacksonville, Florida, 32224

  • MidAmerica Division, Inc. /ID# 222058

    Kansas City, Missouri, 64132

  • Moores Cancer Center at UC San Diego /ID# 164084

    La Jolla, California, 92093

  • Long Beach Memorial Medical Ct /ID# 230148

    Long Beach, California, 90806-1701

  • University of Southern California /ID# 164095

    Los Angeles, California, 90033

  • Tennessee Oncology-Nashville Centennial /ID# 221410

    Nashville, Tennessee, 37203-1632

  • Weill Cornell Medical College /ID# 162679

    New York, New York, 10065

  • Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536

    Normal, Illinois, 61761

  • West Penn Hospital /ID# 222618

    Pittsburgh, Pennsylvania, 15224-1722

  • Utah Cancer Specialists Salt Lake Clinic /ID# 222806

    Salt Lake City, Utah, 84106

  • University of Utah /ID# 164116

    Salt Lake City, Utah, 84112-5500

  • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094

    San Antonio, Texas, 78229

  • Ascension Providence Southfield Cancer Center /ID# 223876

    Southfield, Michigan, 48075-3707

  • Moffitt Cancer Center /ID# 164082

    Tampa, Florida, 33612-9416

  • Prairie Lakes Healthcare System /ID# 224358

    Watertown, South Dakota, 57201

  • University of Massachusetts - Worcester /ID# 222547

    Worcester, Massachusetts, 01655

Other trials in United States

Japan10 sites

  • Aomori Prefectural Central Hospital /ID# 221773

    Aomori, Aomori, 030-8553

  • Juntendo University Hospital /ID# 221484

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital /ID# 222692

    Bunkyo-ku, Tokyo, 113-8602

  • University of Yamanashi Hospital /ID# 221700

    Chuo-shi, Yamanashi, 409-3821

  • Kyushu University Hospital /ID# 222691

    Fukuoka, Fukuoka, 812-8582

  • Kansai Medical University Hospital /ID# 222690

    Hirakata-shi, Osaka, 573-1191

  • Duplicate_Dokkyo Medical University Saitama Medical Center /ID# 222332

    Koshigaya-shi, Saitama, 343-8555

  • Kindai University Hospital /ID# 222689

    Osakasayama-shi, Osaka, 589-8511

  • Sapporo Hokuyu Hospital /ID# 222693

    Sapporo, Hokkaido, 003-0006

  • Fujita Health University Hospital /ID# 221539

    Toyoake, Aichi-ken, 470-1192

Other trials in Japan

Italy8 sites

  • ASST Papa Giovanni XXIII /ID# 214900

    Bergamo, 24127

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 230012

    Bologna, Emilia-Romagna, 40138

  • ASST degli Spedali Civili di Brescia /ID# 230420

    Brescia, 25123

  • AOU Policlinico G. Rodolico - San Marco /ID# 214549

    Catania, 95123

  • Azienda Ospedaliero Universitaria Careggi /ID# 214555

    Florence, Firenze, 50134

  • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 230011

    Reggio Calabria, 89125

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553

    Rome, Roma, 00168

  • ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 214551

    Varese, 21100

Other trials in Italy

Spain8 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 214704

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebron /ID# 222415

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon /ID# 214676

    Madrid, 28007

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719

    Madrid, 28027

  • Hospital Universitario 12 de Octubre /ID# 214710

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria /ID# 214709

    Málaga, 29010

  • Hospital Regional Universitario de Malaga /ID# 230858

    Málaga, 29011

  • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718

    Pamplona, Navarre, 31008

Other trials in Spain

Australia5 sites

  • The Kinghorn Cancer Centre /ID# 214657

    Darlinghurst, New South Wales, 2010

  • Barwon Health /ID# 222430

    Geelong, Victoria, 3220

  • Peter MacCallum Cancer Ctr /ID# 218352

    Melbourne, Victoria, 3000

  • The Alfred Hospital /ID# 215545

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital /ID# 216809

    Murdoch, Western Australia, 6150

Other trials in Australia

United Kingdom5 sites

  • Belfast Health and Social Care Trust /ID# 216991

    Belfast, BT9 7AB

  • Guys and St Thomas NHS Foundation Trust /ID# 164110

    London, Greater London, SE1 9RT

  • The Christie Hospital /ID# 164111

    Manchester, M20 4BX

  • Aneurin Bevan University Health Board /ID# 230332

    Newport, NP18 3XQ

  • Oxford University Hospitals NHS Foundation Trust /ID# 214503

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Croatia4 sites

  • Klinicki Bolnicki Centar (KBC) Split /ID# 230601

    Split, Split-Dalmatia County, 21000

  • Clinical Hospital Dubrava /ID# 230504

    Zagreb, City of Zagreb, 10000

  • Klinicka bolnica Merkur /ID# 230599

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 230602

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Israel4 sites

  • Assuta Ashdod Medical Center /ID# 230396

    Ashdod, Southern District, 7747629

  • Hadassah Medical Center-Hebrew University /ID# 230310

    Jerusalem, Jerusalem, 91120

  • Galilee Medical Center /ID# 230397

    Nahariya, Northern District, 2210001

  • Tel Aviv Sourasky Medical Center /ID# 230311

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Canada3 sites

  • Duplicate_University of Alberta Hospital - Division of Hematology /ID# 217698

    Edmonton, Alberta, T6G 2B7

  • McGill University Health Center Research Institute /ID# 223976

    Montreal, Quebec, H4A 3J1

  • University Health Network_Princess Margaret Cancer Centre /ID# 214483

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hungary3 sites

  • Semmelweis Egyetem /ID# 230518

    Budapest, 1085

  • Duplicate_Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 230306

    Budapest, 1097

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 230585

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

Other trials in Hungary

Greece2 sites

  • General Hospital of Athens Laiko /ID# 230394

    Athens, Attica, 11527

  • Duplicate_University General Hospital Attikon /ID# 230395

    Athens, Attica, 12462

Other trials in Greece

Puerto Rico2 sites

  • VA Caribbean Healthcare System /ID# 222416

    San Juan, 00921-3201

  • Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544

    San Juan, 00927

Other trials in Puerto Rico

South Korea2 sites

  • Seoul National University Hospital /ID# 230380

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 230381

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Taiwan2 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 230371

    Kaohsiung City, Kaohsiung, 833

  • National Cheng Kung University Hospital /ID# 230372

    Tainan, 704

Other trials in Taiwan

About this study

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

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.

Being tested
Ruxolitinib, Navitoclax
Keywords
Post-polycythemia vera MF (PPV-MF), Post-essential thrombocythemia (PET-MF), ruxolitinib, navitoclax, splenic volume, Primary Myelofibrosis, Jakafi, enlarged spleen, splenomegaly, ABT 263, bone marrow fibrosis
Medical subject headings
Primary Myelofibrosis, Splenomegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolitinibDrug

    Also called Jakafi

    Tablet; Oral

  • NavitoclaxDrug

    Also called ABT-263

    Film-coated tablet; Oral

Study groups in NCT03222609
Study groupRoleWhat they receive
Navitoclax + ruxolitinib (Cohort 1a)ExperimentalParticipants 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).
Receives: Drug: Ruxolitinib; Drug: Navitoclax
Navitoclax + ruxolitinib (Cohort 1b)ExperimentalThose 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).
Receives: Drug: Ruxolitinib; Drug: Navitoclax
Navitoclax (Cohort 2)ExperimentalParticipants 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).
Receives: Drug: Navitoclax
Navitoclax + ruxolitinib (Cohort 3)ExperimentalPrior 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).
Receives: Drug: Ruxolitinib; Drug: Navitoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 24

Secondary outcomes (4)

  1. 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).

    Measured: Baseline, Week 24

  2. 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.

    Measured: Up to 254 weeks

  3. 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.

    Measured: Up to 254 weeks

  4. 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.

    Measured: Up to 254 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start31 Oct 2017
  3. Primary completion28 Mar 2022
  4. Study completion29 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03222609
Sponsor's protocol ID
M16-109
Other IDs
2017-001398-17, 2017
Acronym
REFINE
Status last verified
Dec 2025
First submitted
17 Jul 2017
Last updated
20 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Rampal RK, Harrison CN, Mesa R, Vannucchi AM, Shimoda K, Perkins A, Garcia JS, Reiter A, Radinoff A, Pane F, Palandri F, Lomaia E, Lee SE, Chuah HS, Passamonti F, Saydam G, Turgut M, Yoon SS, Bain EE, Lam H, Jain S, Potluri J, Kiladjian JJ. Navitoclax monotherapy or in combination with ruxolitinib in patients with JAK2 inhibitor-treated myelofibrosis: results from the phase 2 REFINE and phase 3 TRANSFORM-2 studies. Leuk Lymphoma. 2026 Oct 7:1-11. doi: 10.1080/10428194.2026.2739358. Online ahead of print.

    PubMed 42842696

  • Passamonti F, Foran JM, Tandra A, De Stefano V, Fox ML, Mattour A, McMullin MF, Perkins AC, Rodriguez-Macias G, Sibai HA, Polepally AR, Sun Y, Chopra AS, Harb JG, Qin Q, Potluri J, How J. Preliminary Safety and Efficacy of Navitoclax Plus Ruxolitinib in Janus Kinase Inhibitor-Naive Patients With Myelofibrosis From the Multicenter, Open-Label, Phase 2 Study (REFINE). Hematol Oncol. 2026 Mar;44(2):e70180. doi: 10.1002/hon.70180.

    PubMed 41846295

  • 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.

    PubMed 40454409

  • 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.

    PubMed 35576960

  • 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.

    PubMed 35180010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib and Navitoclax in people with Myelofibrosis (MF), run by AbbVie at 91 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Japan, Italy, Spain, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222609, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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