MedTrace Logo

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

NCT04055844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-11-07

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Armin Rashidi, MD, PhD · Division of Hematology, Oncology and Transplantation, University of Minnesota

  • Mark A Schroeder, M.D. · Washington University School of Medicine

  • John F Dipersio, M.D., Ph.D. · Washington University School of Medicine

  • Eric Huselton, M.D. · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2022-09-06
Completion
2022-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055844 on ClinicalTrials.gov