Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

September 6, 2022

Study Completion Date

September 6, 2022

Conditions
Acute Myeloid LeukemiaMyeloid and Monocytic LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

Decitabine

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.

DRUG

Ruxolitinib

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.

DRUG

Donor Lymphocyte Infusion (DLI)

DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.

Trial Locations (3)

14642

University of Rochester Medical Center, Rochester

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

63130

Washington University Medical School, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

Masonic Cancer Center, University of Minnesota

OTHER