This is a multi-center, single-arm, open-label, phase II trial for the frontline treatment of relapsed AML or MDS following allo-HCT. Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Washington University Medical School
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS)
Rate of Overall Survival (OS)
Time frame: 6 Months
Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS)
Rate of Overall Survival (OS)
Time frame: 1 Year
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Time frame: 3 Months
Progression Free Survival (PFS)
Rate of Progression Free Survival (PFS)
Time frame: 6 Months
Progression Free Survival (PFS)
Rate of Progression Free Survival (PFS)
Time frame: 1 Year
Relapse
Cumulative Incidence of Relapse
Time frame: 6 Months
Relapse
Cumulative Incidence of Relapse
Time frame: 1 Year
Complete Remission (CR)
Rate of Complete Remission (CR)
Time frame: 6 Months
Complete Remission (CR)
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Rate of Complete Remission (CR)
Time frame: 1 Year
Non-Relapse Mortality (NRM)
Cumulative Incidence of Non-Relapse Mortality (NRM)
Time frame: 6 Months
Non-Relapse Mortality (NRM)
Cumulative Incidence of Non-Relapse Mortality (NRM)
Time frame: 1 Year
Best Response
Best response until next line of treatment, death, or last follow up, whichever occurs sooner
Time frame: 1 Year