Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

Study Overview
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Brief Summary
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Determine the efficiency of a myéloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.

Official Title
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Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

Conditions
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Hematological Diseases

Intervention / Treatment
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* Drug: Allogeneic transplant conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Informed consent signed, Patient affiliated to a social security system or benefiting from such a system, Related HLA identical donor or unrelated HLA identical donor : all patients aged > 55 years with hematological malignancy and deemed eligible for an allogeneic transplant from a geno-identical donor and pheno-identical 10/10 - the basic pathology should be considered chemo-sensitive complete or partial remission (CR, PR) or stable disease Exclusion Criteria : Pregnant or lactating woman or without contraception (for child bearing potential women) Patient deprived of liberty or under supervision of a guardian Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons Usual contra-indications for allogenic transplant Aged < 55 years History of allogenic transplant Concomitant neoplastic disease Evolutive psychiatric disease HIV seropositivity or C hepatitis under treatment Women of childbearing age or man, in the absence of effective contraception during treatment and up to 12 months after treatment discontinuation

Ages Eligible for Study
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Minimum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Busulfan with adapted doses<br>Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine) | Drug: Allogeneic transplant conditioning<br>* Allogeneic transplant<br>* Other names: Busulfan, thymoglobuline, fludarabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates progression free survival 2 years |  | Time to progression or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic concentration of Busulfan |  | Time from inclusion until Day -1 before allogenic transplantation |