Back to resultsStudy Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases (BX-PK)
Primary Purpose
Hematological Diseases
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Allogeneic transplant conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Diseases
Eligibility 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
Sites / Locations
- Institut Paoli Calmettes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Busulfan with adapted doses
Arm Description
Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)
Outcomes
Primary Outcome Measures
rates progression free survival 2 years
Secondary Outcome Measures
Plasmatic concentration of Busulfan
Full Information
NCT ID
NCT02483325
First Posted
June 24, 2015
Last Updated
January 22, 2019
Sponsor
Institut Paoli-Calmettes
Collaborators
Agence de La Biomédecine
1. Study Identification
Unique Protocol Identification Number
NCT02483325
Brief Title
Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2020 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Agence de La Biomédecine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Busulfan with adapted doses
Arm Type
Other
Arm Description
Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)
Intervention Type
Drug
Intervention Name(s)
Allogeneic transplant conditioning
Other Intervention Name(s)
Busulfan, thymoglobuline, fludarabine
Intervention Description
Allogeneic transplant
Primary Outcome Measure Information:
Title
rates progression free survival 2 years
Time Frame
Time to progression or death
Secondary Outcome Measure Information:
Title
Plasmatic concentration of Busulfan
Time Frame
Time from inclusion until Day -1 before allogenic transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.institutpaolicalmettes.fr
Description
official web site of the sponsor
Learn more about this trial
Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
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