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HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

NCT02461121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2015-06-04

No results posted yet for this study

Summary

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Conditions

Interventions

GENETIC

HLA mismatched stem cell

HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy

GENETIC

HLA matched stem cell

HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen

DRUG

cyclosporine A

The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil

DRUG

Mycophenolate mofetil

The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil

DRUG

Ara-C

2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose

DRUG

fludarabine

30 mg/m2/d for 5days

DRUG

anti-lymphocyte globulin

1.5-2 mg/kg/d for 4 days

DRUG

cyclophosphamide

40 mg/kg/d for 2 days

Sponsors & Collaborators

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • ai huisheng · Affiliated Hospital of Academy of Military Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02461121 on ClinicalTrials.gov