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

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Collaborator: Agence de La Biomédecine
• Treatments: Busulfan; Fludarabine; Thymoglobulin

Criteria

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