Overview

A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

Status:
Completed

Trial end date:
2013-02-01

Target enrollment:
0

Participant gender:
All

Summary

This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC). Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day). Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI). A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches. Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB). Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent. Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Institut Paoli-Calmettes

Criteria

Inclusion Criteria:

- hematological malignancy or solid tumor,

- eligible for non myeloablative allogenic transplantation,

- aged between 18 and 65,

- with a suitable HLA identical sibling

Exclusion Criteria:

- contra-indication to allogenic transplantation

- pregnant women or breast feeding

- active infection