Phase I/II Study of Ruxolitinib Plus Decitabine in Patients with Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)
This clinical research study is made up of 2 parts: Phase 1 and Phase 2. The goal of Phase 1 of this study is to find the highest tolerable dose of the combination of decitabine and ruxolitinib that can be given to patients with AML. The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML). The safety of the drug combination will be studied in both phases.
Disease Group: Leukemia,Myeloproliferative Diseases
Treatment Agent: Decitabine,Ruxolitinib
Treatment Location: Only at MD Anderson
For phase I portion of study: --To determine the tolerability of the combination of decitabine and Ruxolitinib (DI) in patients with Leukemia. For phase II portion of study: --Primary objective - To determine the efficacy of Ruxolitinib in increasing and prolonging response induced by decitabine alone in patients with post myeloproliferative neoplasm AML (post MPN-AML) alternatively referred to as (myeloproliferative neoplasm - blast phase MPN-BP).(Compared to historical response rate with decitabine alone) --Secondary objective - To compare whether there is a difference in response rate patients with post-MPN AML with JAK2 mutations and patients without JAK2 mutations.
IRB Review and Approval Date: 02/12/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Diagnosis of AML (WHO classification definition of > or = to 20% blasts)
2) In the phase I portion of the study all patients with relapsed or refractory AML are eligible. For the Phase II portion of the study, patients must have AML progressing from prior MPN (MPN-BP) or have MDS/MPN with more than 20% blasts. Temporary prior measures to control blood counts, such as apheresis or hydrea are allowed. Patients with newly diagnosed or previously treated disease are eligible as long as prior therapy does not include hypomethylating agents. Prior therapy for RUXOLITINIB for MPN is allowed.
3) Serum biochemical values with the following limits unless considered due to leukemia: --- Creatinine < or= to 1.5mg/dl ---- total bilirubin < or = to 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder ---- transaminases (SG PT) < or = to 2.5x ULN
4) Ability to take oral medication.
5) Ability to understand and provide signed informed consent.
6) Performance status < or = to 3, unless directly related to disease process as determined by the Principal Investigator.
7) Age > or = 18 years
1) Any coexisting medical condition that in the judgment of the treating
physician is likely to interfere with study procedures or results
including uncontrolled severe infections, as well as uncontrolled
cardiac disease, or other organ dysfunction. Patients with history of
tuberculosis, HIV or hepatitis B and C are excluded.
2) Nursing women, women of childbearing potential with positive blood pregnancy test within 30 days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
3) Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access.
4) Active clinically serious and uncontrolled infection
Information and next steps
Phase I/Phase II
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