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

Study Overview
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Brief Summary
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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).

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

Conditions
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Allograft, Allogeneic Cell Transplantaion, Hematological Malignancy, Solid Tumor

Intervention / Treatment
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* Drug: reduced intensity conditionings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flu-Bu-ATG<br>Fludarabine (30mg/m²/5 days) Oral Busulfan (8 mg/kg over 2 days) Thymoglobuline (2.5 mg/m²/1day). | Drug: reduced intensity conditionings<br>* comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)<br>|
| Experimental: Fluda-TBI<br>Fludarabine (25mg/m²/ 3 days) 2 Gy TBI | Drug: reduced intensity conditionings<br>* comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year overall survival (OS) |  | one year |