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HMA+DLI vs DLI Preemptive Therapy Based on MRD for AL Undergoing Allo-HSCT

NCT03662087 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-09-07

No results posted yet for this study

Summary

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. In this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (HMA) + DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.

Conditions

  • Minimal Residual Disease,Acute Leukemia, Hypomethylating Agents, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Cell Transplantation

Interventions

COMBINATION_PRODUCT

HMA+DLI

HMA: Decitabine was administered at 20mg/m2/day for five consecutive days or Ara-C was administered at 75mg/m2/day for seven consecutive days. DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.

BIOLOGICAL

DLI

DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2021-10-31
Completion
2022-10-31

Countries

  • China

Study Locations

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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 NCT03662087 on ClinicalTrials.gov