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

Institut Paoli-Calmettes

Status and phase: Completed; Phase 2

Conditions: Hematological Diseases

Treatments: Drug: Allogeneic transplant conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02483325

BX-PK-IPC 2013-016

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Busulfan with adapted doses

Other group

Description:

Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)

Treatment:

Drug: Allogeneic transplant conditioning