Status:
COMPLETED
Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Blasts More Than 20 Percent of Bone Marrow Nucleated Cells
Blasts More Than 20 Percent of Peripheral Blood White Cells
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of ruxolitinib phosphate when given together with decitabine and to see how well they work in treating patients with acute myeloid leukemia...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the tolerability of the combination of decitabine and ruxolitinib phosphate (ruxolitinib \[DI\]) in patients with leukemia. (Phase I) II. To determine the efficacy...
Eligibility Criteria
Inclusion
- Diagnosis of AML (World Health Organization \[WHO\] classification definition of \>= to 20% blasts)
- 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 myelodysplastic syndrome (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
- Serum biochemical values with the following limits unless considered due to leukemia:
- Creatinine =\< 1.5 mg/dl
- Total bilirubin =\< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
- Transaminases (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x upper limit of normal (ULN)
- Ability to take oral medication
- Ability to understand and provide signed informed consent
- Performance status =\< 3, unless directly related to disease process as determined by the principal investigator
Exclusion
- 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, human immunodeficiency virus (HIV) or hepatitis B and C are excluded
- 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, intrauterine device \[IUD\], diaphragm, abstinence, or condoms by their partner) over the entire course of the study
- Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access
- Active clinically serious and uncontrolled infection
Key Trial Info
Start Date :
February 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02257138
Start Date
February 12 2015
End Date
March 19 2021
Last Update
June 8 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030