Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
Phase 2
Completed
- Conditions
- Hematological Diseases
- Interventions
- Drug: Allogeneic transplant conditioning
- Registration Number
- NCT02483325
- Lead Sponsor
- Institut Paoli-Calmettes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Busulfan with adapted doses Allogeneic transplant conditioning Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)
- Primary Outcome Measures
Name Time Method rates progression free survival 2 years Time to progression or death
- Secondary Outcome Measures
Name Time Method Plasmatic concentration of Busulfan Time from inclusion until Day -1 before allogenic transplantation
Trial Locations
- Locations (1)
Institut Paoli Calmettes
🇫🇷Marseille, France