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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Hematological Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Busulfan with adapted doses

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

Group Type OTHER

Allogeneic transplant conditioning

Intervention Type DRUG

Allogeneic transplant

Interventions

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Allogeneic transplant conditioning

Allogeneic transplant

Intervention Type DRUG

Other Intervention Names

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Busulfan, thymoglobuline, fludarabine

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No