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

Phase 2

Completed

• Conditions: Allograft; Allogeneic Cell Transplantaion; Hematological Malignancy; Solid Tumor
• Interventions: Drug: reduced intensity conditionings

• Registration Number: NCT00894049
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flu-Bu-ATG	reduced intensity conditionings	Fludarabine (30mg/m²/5 days) Oral Busulfan (8 mg/kg over 2 days) Thymoglobuline (2.5 mg/m²/1day).
Fluda-TBI	reduced intensity conditionings	Fludarabine (25mg/m²/ 3 days) 2 Gy TBI

Primary Outcome Measures

Name	Time	Method
one year overall survival (OS)	one year

Trial Locations

Locations (2)

CHU; 🇫🇷 Montpellier, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France