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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:

Paoli-Calmettes Institute

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

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 33 participants
Masking : NONE
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 : 2014-09
Estimated Primary Completion Date : 2018-03
Estimated Study Completion Date : 2020-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Location Details

NCT02483325

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Paoli Calmettes Institute

Marseille, France, 13009