NCT01985061CompletedPhase 2
Evaluation of 3 Different Doses of IV Busulfan
Prospective and Multicentre Evaluation of 3 Different Doses of IV Busulfan Associated With Fludarabine and Thymoglobuline in the Conditioning of Allogeneic Stem Cell Transplantation (SCT) From a Matched Related or Unrelated Donor in Patients With Poor Prognosis Myeloid Malignancies
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies. The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design. In addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 177 (estimated)
- First submitted
- 31 Oct 2013
- Start date
- Dec 2013
- Primary completion date
- 27 May 2026
- Lead sponsor
- Institut Paoli-Calmettes
- NCT number
- NCT01985061
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 177
- From Dec 2013 to the primary completion date, 27 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous Allo-Hematological Stem Cell Transplantation (HSCT)
- Concomitant neoplastic disease
Other illness
- HIV positivity
- Signs of chronic active hepatitis B and/or C
- Evolutive psychiatric disease
Other
- Pregnant or lactating woman or without contraception (for child bearing potential wom-en)
- Usual contra-indications for Allo-HSCT
Who the study is looking for
- Patients with poor prognosis myeloid malignancies:
- Myelodysplastic syndrome,
- Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),
- CR1 AML with poor risk cytogenetics
- 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.
- Availability of a HLA identical sibling or matched unrelated donor (10/10)
- Affiliation to social security
- Written Informed Consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.