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

  • End date
    Feb 2, 2029
  • participants needed
  • sponsor
Updated on 29 April 2021
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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.


Condition Myelofibrosis
Treatment Ruxolitinib, Navitoclax
Clinical Study IdentifierNCT03222609
Last Modified on29 April 2021


Yes No Not Sure

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

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
Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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