Determine the efficacy and tolerability of appropriate doses of busulfan to administer in patients with high risk of hematological disease.

Phase 1

• Conditions: hematological malignancies : Acute Myeloblastic Leukemia, Chronic Lymphoïd Leukemia, Multiple myéloma, Acute lymphoblastic leukemia.; MedDRA version: 17.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10000878Term: Acute myeloblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000758-12-FR
• Lead Sponsor: INSTITUT PAOLI CALMETTES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 33

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified