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NCT02483325 | Completed | Hematological Diseases

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

Condition or disease

Hematological Diseases

Intervention/treatment

Allogeneic transplant conditioning

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 33 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020
Arm Intervention/treatment

Other: Busulfan with adapted doses

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

Drug: Allogeneic transplant conditioning
Ages Eligible for Study: 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
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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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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Locations

Not yet recruiting

France,

Institut Paoli Calmettes

Marseille, France, 13009