Evaluation of 3 Different Doses of IV Busulfan

Official record

Identifier

NCT01985061

Recruiting locations

country

France

Interventions studied

BX2BX3BX4-Suspended

Lead sponsor

Institut Paoli-Calmettes

Target enrolment

177 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Completed

First posted

Nov 15, 2013

Last updated on the registry

Oct 1, 2026

Age

18 Years – 65 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Patients with poor prognosis myeloid malignancies:

   * Myelodysplastic syndrome,
   * Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),
   * CR1 AML with poor risk cytogenetics
2. Adult patients: aged ≥ 55 years up to 65 or \< 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.
3. Availability of a HLA identical sibling or matched unrelated donor (10/10)
4. Affiliation to social security
5. Written Informed Consent

Exclusion Criteria:

1. History of previous Allo-Hematological Stem Cell Transplantation (HSCT)
2. HIV positivity
3. Signs of chronic active hepatitis B and/or C
4. Evolutive psychiatric disease
5. Concomitant neoplastic disease
6. Pregnant or lactating woman or without contraception (for child bearing potential wom-en)
7. Usual contra-indications for Allo-HSCT

Indexed under

Leukemia