A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)
- Conditions
- MyelofibrosisMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507276-53-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 191
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method