NCT00894049

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Allograft
• Allogeneic Cell Transplantaion
• Hematological Malignancy
• Solid Tumor

Interventions

Type	Name	Description
DRUG	reduced intensity conditionings	comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)

Timeline

• Start date: 2002-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-05-06
• Last updated: 2014-01-01

Locations

5 sites across 1 country: France