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Clinical Trial NCT01985061 (AAA) for Myelodysplastic Syndrome, Acute Myeloid Leukemia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Evaluation of 3 Different Doses of IV Busulfan (AAA) Phase 2 177 Pharmacogenomic Observational

Active, not recruiting
Clinical Trial NCT01985061 (AAA) is designed to study Treatment for Myelodysplastic Syndrome, Acute Myeloid Leukemia. It is a Phase 2 interventional study that is active, not recruiting, having started on 1 December 2013, with plans to enroll 177 participants. Led by Institut Paoli-Calmettes, it is expected to complete by 7 July 2026. The latest data from ClinicalTrials.gov was last updated on 15 June 2025.
Brief Summary
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 t...Show More
Official Title

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

Conditions
Myelodysplastic SyndromeAcute Myeloid Leukemia
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • AAA
  • AAA-IPC2011-003
NCT ID Number
NCT01985061
Start Date (Actual)
2013-12
Last Update Posted
2025-06-15
Completion Date (Estimated)
2026-07-07
Enrollment (Estimated)
177
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Myelodysplasic syndrome
Acute Myeloid leukemia
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorBX2
Fludarabine (Fludara®): 30 mg/m2 on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-4 and D-3 Thymoglobuline®: 2.5 mg/kg/d on D-3 and D-2
BX2
ExperimentalBX3
Fludarabine (Fludara®): 30 mg/m² on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2
BX3
Active ComparatorBX4-Suspended
Fludarabine (Fludara®): 30 mg/m²on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-6, D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2
BX4-Suspended
Suspended
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time to progression or death
2-year progression free survival rates
up to 2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time to neutrophil>0.5G/l and platelets>50G/l
hematologic recovery
up to 2 months
Graft versus host disease
up to 2 years
relapse
up to 2 years
Occurrence of grade 3-4 adverse events according the CTC-AE v4.0 scale
safety
up to 6 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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

  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
Institut Paoli-Calmettes logoInstitut Paoli-Calmettes
No contact data.
1 Study Locations in 1 Countries
Institut Paoli Calmettes, Marseille, 13009, France