Chronic Leukaemia

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Protocol ALLO-MDS 2x2

A prospective 2 x 2 randomized multicenter study evaluating the role of remission-induction and consolidation chemotherapy prior to allogeneic transplantation and of G-CSF mobilized peripheral blood progenitor cells versus bone marrow stem cells using HLA-identical siblings in patients less than 50 years of age with myelodysplastic syndromes and 5% to 20% bone marrow blasts.

Trial management:

Trial Co-ordination and Data Management:
Alain Barrois (EBMT Clinical Trials Office Leiden)
Tel: +31 71 526 9722

Coordinating investigators:
Philippe Guardiol (Angers) and Theo M de Witte (Nijmegen)

Statistician:
Ronald Brand (Leiden)

Click on the links below to download relevant documents in format

• Protocol
  
  • Current Protocol
  • For previous versions of the protocol click here
• Summary of the protocol
  • Croatian
  • Dutch
  • English
• Patient and donor information
  • Documents
• Registration form
  • Form
• Case Report Form (CRF) and Severe Adverse Event form (SAE)
  • CRF
  • SAE
• Chief Investigators (this list will grow while new countries start participating in the trial)
  • Belgium: L. Noens
  • Croatia: B. Labar
  • Czech Republic: V. Koza
  • France: Ph. Guardiola
  • Germany: B. Hertenstein
  • Italy: W. Arcese
  • Netherlands: Th. de Witte
  • Norway: L. Brinch
  • Spain: J. Moraleda
  • Switzerland: A. Gratwohl
  • United Kingdom: G. Mufti
• Flowchart

1. Registration of patients with MDS.
2. Double randomization: random-RI (remission-induction + consolidation chemotherapies vs. no chemotherapy) and
random-SC (G-CSF mobilized peripheral blood progenitor cells vs. bone marrow stem cells) done at the same time, with the Registration process.
3. Three remission-induction regimens can be used.
4. Allogeneic transplantation with either G-CSF mobilized peripheral blood progenitor cells or bone marrow stem cells according to random-SC.
5. One consolidation course is performed if a complete remission (CR) is achieved.