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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT04055844
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    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.
  • Ruxolitinib — DRUG
    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.
  • Donor Lymphocyte Infusion (DLI) — DRUG
    DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.

Study Details

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.

Key Dates

Start date
Feb 17, 2020
Status verified
Nov 2023
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Decitabine + Ruxolitinib + DLI
    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.

Primary Outcome Measure

Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS) [ Time Frame: 6 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-
Washington University Medical SchoolSt LouisMissouri63130-
University of Rochester Medical CenterRochesterNew York14642-

Find similar trials in Minneapolis, MN

By condition
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By specialty
OncologyBlood cancer
By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MNWashington University Medical School· St Louis, MOUniversity of Rochester Medical Center· Rochester, NY

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