Clinical Trials Directory

Trials / Completed

CompletedNCT04055844

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDecitabine10 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.
DRUGRuxolitinibStarting 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.
DRUGDonor Lymphocyte Infusion (DLI)DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.

Timeline

Start date
2020-02-17
Primary completion
2022-09-06
Completion
2022-09-06
First posted
2019-08-14
Last updated
2023-11-07
Results posted
2023-11-07

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04055844. Inclusion in this directory is not an endorsement.