At a glance
ClinicalIndex Comparison Record- ✓Age ≥12 years
- ✓Prior allogeneic hematopoietic stem cell transplantation from matched sibling, matched unrelated, or haploidentical donor
- ✓History of AML or MDS (including overlap MPN/MDS) for which allo-HCT was performed
- ✓Untreated relapse with >5% malignant blasts in bone marrow or myeloid sarcoma
- ✕Active uncontrolled infection at time of consent
- ✕HIV, unresolved hepatitis B, or hepatitis C
- ✕Untreated CNS leukemia
- ✕Untreated or active GVHD; prior history of grade III-IV acute GVHD
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Phase 2 Study of Combined Modality Treatment With Ruxolitinib, Decitabine, and Donor Lymphocyte Infusion for Post-Transplant Relapse of AML or MDS
In Brief
A Phase 2 clinical trial evaluating Decitabine, Ruxolitinib, and 1 other intervention for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 14 participants across 3 sites.
Detailed Summary
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 Details
Timeline
Interventions
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.