Solid Tumor Clinical Trial
Official title:
A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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