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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02483325

Acronym

BX-PK

Enrollment

Registered

2015-06-26

Start date

2014-09-30

Completion date

2020-03-31

Last updated

2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Diseases

Brief 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.

Interventions

DRUGAllogeneic transplant conditioning

Allogeneic transplant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
rates progression free survival 2 years	Time to progression or death

Secondary

Measure	Time frame
Plasmatic concentration of Busulfan	Time from inclusion until Day -1 before allogenic transplantation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026