A Phase III Study Comparing the Combination of Navitoclax and Ruxolitinib with Standard Treatment in People with Myelofibrosis

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Full Title

A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

Purpose

Myelofibrosis is disease that causes scarring of the bone marrow. The drug navitoclax may be effective against myelofibrosis because it may promote cancer cell death by blocking certain proteins and prevent further bone marrow scarring. In this study, researchers are assessing treatment with navitoclax plus ruxolitinib (a standard myelofibrosis treatment) compared with standard treatment in people with myelofibrosis that has come back or continued to get worse despite therapy.

Participants in this study will be randomly assigned to receive either navitoclax plus ruxolitinib OR a standard myelofibrosis therapy (fedratinib, ruxolitinib, hydroxyurea, PEG-interferon-alpha-2, or danazol). Navitoclax and ruxolitinib are both taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have myelofibrosis that that has come back or continued to get worse despite therapy that included ruxolitinib.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 646-608-3746.

Protocol

21-311

Phase

III

Investigator

Co-Investigators