[M16-109] A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis (REFINE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210029

Enrollment

Registered

2021-06-09

Start date

2021-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Interventions

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).

Eligibility

Sex/Gender

All

Inclusion criteria

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 or unwilling to undergo stem cell transplantation at time of study entry. - Eastern Cooperative Oncology Group (ECOG) of 0,1, or 2. - Participant must have either received prior treatment with ruxolitinib OR another Janus Kinase 2 (JAK-2) inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor 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

Exclusion criteria: - Splenic irradiation within 6 months prior to screening, or prior splenectomy. - Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy). - Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin. - Prior therapy with a BH3 mimetic compound or stem cell transplantation. - Participant has received strong or moderate 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.

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline [ Time Frame: From Baseline (Week 0) through Week 24 ]	—

Countries

Australia, Belgium, Bulgaria, Canada, Croatia, France, Greece, Hungary, Israel, Italy, Japan, Korea, Poland, Puerto Rico, Russia, Serbia, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026