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Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia

NCT00224614 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2005-12-14

No results posted yet for this study

Summary

The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55 years, because it offers chances of cure higher than chemotherapy or the auto-graft. However, mortality related to the traditional graft is approximately 30% to 1 year. The recent use of the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on the allogenic effect "graft-versus-leukaemia" makes it possible to obtain among patients of more than 55 years in complete reemission (CR), survivals without relapses comparable with the traditional allograft among patients of more than 35 years. The major interest of NMA graft is to reduce early mortality related to the graft. This reduction should be all the more significant as the patient is younger, and thus bring to a better survival. There is not, at the present hour, of prospective comparative study of the two procedures of graft. Taking into account the results observed after NMA graft among patients of more than 55 years, and taking into account the toxicity of the standard graft between 35 and 55 years, it is essential to now compare the 2 approaches among patients who do not have a counter-indication for one or the other, in the age bracket where the toxicity of the traditional graft is highest.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

PROCEDURE

Allogenic transplantation

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • CORDONNIER Catherine, Professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Completion
2009-07-31

Countries

  • France

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 NCT00224614 on ClinicalTrials.gov