IRB #

STUDY00018059

Title

A Phase I/II, open-label, multi-center study evaluating the safety and efficacy of Ruxolitinib and CPX-351 in combination for the treatment of Secondary Acute Myeloid Leukemia Transformed from Myeloproliferative Neoplasms.

Principal Investigator

Uma Borate

Study Purpose

Patients with myeloproliferative neoplasms (MPNs) that undergo transformation to acute myelogenous leukemia (AML) have poor clinical outcomes. The safety and efficacy of the liposomal formulation of cytarabine and daunorubicin (CPX-351) will be assessed in combination with ruxolitinib to treat patients with post-MPN AML. The study will also look at the following:

• maximum tolerated dose (MTD) of ruxolitinib in combination with CPX-351best objective response rate during the first 2 cycles of treatment
• bone marrow cellularity
• instances of adverse events
• twelve month overall survival
• twelve month progression-free survival
• treatment-related toxicity

Medical Condition(s)

Secondary Acute Myeloid Leukemia Transformed from Myeloproliferative Neoplasms

Eligibility Criteria

Patients diagnosed with post-MPN AML.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment period is anticipated to be ~12 months with 1 year of follow-up.

Minors Included

No

Contact

Madison Hayes
hayema@ohsu.edu
503-494-3835

Sponsor

Incyte and Jazz Pharmaceuticals

Recruitment End

12/31/2023

Compensation Provided

No


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