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

Hematological Diseases Clinical Trial

— BX-PK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483325
• Other study ID #: BX-PK-IPC 2013-016
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: March 2020

Study information

• Verified date: January 2019
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Diseases

Intervention

Drug:
• Allogeneic transplant conditioning
Allogeneic transplant

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Agence de La Biomédecine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rates progression free survival 2 years		Time to progression or death
Secondary	Plasmatic concentration of Busulfan		Time from inclusion until Day -1 before allogenic transplantation

External Links

•   official web site of the sponsor