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A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)
EU CTIS ID: 2023-507276-53-00
What this study is testing
Evaluate the effect of navitoclax alone or in combination with ruxolitinib on spleen volume
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects ≥ 18 years of age
- Cohorts 1b and 3 only: Subject 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
- Subject has splenomegaly defined as spleen palpation measurement ≥ 5 cm below costal margin or spleen volume ≥ 450 cm3 as assessed by MRI/CT
- Subject must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
- Subjects with documented diagnosis of Intermediate or High-risk Primary myelofibrosis, post-polycythemia vera myelofibrosis or postessential thrombocythemia myelofibrosis
- Subjects classified as intermediate-2 or high-risk myelofibrosis, as defined by the Dynamic International Prognostic Scoring System (DIPSS)
You likely can't join if
- Splenic irradiation within 6 months prior to screening, or prior splenectomy.
- Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy).
- Prior therapy with a BH3 mimetic compound or stem cell transplantation.
See the full eligibility criteria
- Subjects ≥ 18 years of age
- Cohorts 1b and 3 only: Subject 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
- Subject has splenomegaly defined as spleen palpation measurement ≥ 5 cm below costal margin or spleen volume ≥ 450 cm3 as assessed by MRI/CT
- Subject must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
- Subjects with documented diagnosis of Intermediate or High-risk Primary myelofibrosis, post-polycythemia vera myelofibrosis or postessential thrombocythemia myelofibrosis
- Subjects classified as intermediate-2 or high-risk myelofibrosis, as defined by the Dynamic International Prognostic Scoring System (DIPSS)
- Subject 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
- ECOG 0, 1, or 2
- Cohort 1a only: Subject must have received ruxolitinib therapy for at least 12 weeks and be currently on a stable dose of ≥ 10 mg twice daily of ruxolitinib for ≥ 8 weeks prior to the 1st dose of navitoclax.
- Cohort 1b only: Subject must have received treatment with ruxolitinib for ≥ 24 weeks with lack of efficacy OR for < 24 weeks with documented disease progression while on ruxolitinib OR for ≥ 28 days with intolerance defined as new RBC transfusion requirement
- Cohort 2 only: Subject must have received prior treatment with JAK-2 inhibitor therapy for at least 12 weeks OR for ≥ 28 days complicated by 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
- Cohort 3 only: Subject must not have received prior treatment with a JAK-2 or BET inhibitor
- Splenic irradiation within 6 months prior to screening, or prior splenectomy.
- Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy).
- Prior therapy with a BH3 mimetic compound or stem cell transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Korea, Republic of
- Serbia
- Taiwan
- Japan
- Australia
- United Kingdom
- Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Korea, Republic of; Serbia; Taiwan; Japan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.