hematological malignancies : Acute Myeloblastic Leukemia, Chronic Lymphoïd Leukemia, Multiple myéloma, Acute lymphoblastic leukemia. MedDRA version: 17.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10000878 Term: Acute myeloblastic leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BUSULFAN
Product Name: BUSILVEX
Product Code: L01AB01
Pharmaceutical Form: Solution for infusion
Sponsors
INSTITUT PAOLI CALMETTES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent to participate signed 2. Affiliation to a social security scheme, or beneficiary of such a system, 3. Related or unrelated donor HLA identical: All patients age = 55 years with hematologic malignancies and considered eligible for an allogeneic transplant from a donor genotype and phenotype identical identical 10/10, 4. The basic pathology should be considered "chemo-sensitive" complete or partial remission (CR, PR) or stable disease (SD). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or likely to be (without effective contraception) or breastfeeding woman 2. Person in an emergency situation, a major person under a legal protection measure (major guardianship, curatorship or judicial protection), or unable to consent, 3. Inability to undergo medical monitoring test for geographical, social or psychological reasons, 4. Cons-indications for allogeneic transplantation, 5. Age <55 years 6. Previous allograft 7. Convert cancerous progressive disease concomitantly 8. Evolutionary psychiatric condition, 9. Seropositive for human immunodeficiency virus or hepatitis C scalable requiring treatment, 10. Women of childbearing potential and men, in the absence of effective contraception during treatment and for 12 months after stopping treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the effectiveness of a myeloablative conditioning combining fludarabine, thymoglobulin, and intravenous busulfan in appropriate dose based on pharmacokinetic study made the first day of administration of busulfan in preparation for allogeneic HLA-compatible family or non-family.;Secondary Objective: - Study of pharmacokinetics of intravenous busulfan performed on day 1 of administration (or J-6 packaging), and allowing the adaptation of doses remaining three days of administration of busulfan, and J-2 to monitor patient exposure. - Determine the tolerance according to the usual criteria of allograft, that is to say chimerism (M1, M2 and M3), hematologic recovery, the rate of response to treatment, the incidence of graft against the host (GVH) acute and chronic, relapse and mortality unrelated to relapse, overall survival, and tolerance to 6 months.;Primary end point(s): Evaluate the progression free survival at 2 years;Timepoint(s) of evaluation of this end point: date of progression disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Plasma concentration of busulfan, - Death is not related to the disease (NRM), - Effect of acute and chronic GVHD GVHD, - Haematological recovery, - Engraftment and chimerism full 100 donor - Incidence of relapse, - Overall Survival.;Timepoint(s) of evaluation of this end point: Pharmacokinetic study Date of death disease status and MPG up to 24 months engraftment and full donor chimerism 100% aus months 1, 2 and 3 | — |
Countries
France
Contacts
Public ContactDIRECTOR OF DRCI
INSTITUT PAOLI CALMETTES
Outcome results
None listed