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Evaluation of 3 Different Doses of IV Busulfan

Study acronym: AAA
StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 7, 2026 to May 27, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Publications: details revised at 1 of 1 entry
  2. 2 versions Re-verified since Jun 10, 2025, no change to tracked fieldsv9-v10
  3. Primary and study completion dates: Dec 2018 to Jul 7, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  4. Interventions: BX2 (Drug), BX3 (Drug), BX4 (Drug) to BX2 (Drug), BX3 (Drug), BX4-Suspended (Drug)v7
  5. 3 versions Re-verified since Mar 4, 2016, no change to tracked fieldsv4-v6
Show 2 earlier versionsHide 2 earlier versions
  1. Site contact updatedv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Nov 2018 to Dec 2018
    • Study completion date: Dec 2018
    • Start date: Nov 2013 to Dec 2013
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT01985061
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Myelodysplastic Syndrome, Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov