HOVON HO34 MDS

Archived

Main info

Identifier:
HO34 MDS / EORTC 06961
Sponsor:
HOVON
Active sites:
0
(of 1)
1 sites are pending
Title:

Autologous Peripheral Blood Stem Cell Transplantation (PSCT) versus a second Intensive Consolidation Course after a Common Induction and Consolidation Course in Patients with bad prognosis Myelodysplatic Syndromes (MDS) and Acute Myelogenous Leukemia secondary (SAML) to MDS of more than 6 months duration: A Phase III Study.

Timeline

Scheduled
Actual
1996
15 Dec
Activated
2006
15 Dec
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • All patients with untreated RAEBt, RAEB with > 10% blast cells in the bone marrow, other forms of MDS with multiple chromosomal abnormalities, and/or profound cytopenias, and secondary AML supervening after overt MDS of more than 6 months duration are eligible for the study.
  • Patients between 10 and 60 years.
  • Informed consent and expected cooperation of the patient with regard to treatment and follow-up.
  • Performance status according to WHO: scale 0, 1 or 2.
Exclusion Criteria:
  • Blast crisis of chronic myeloid leukemia.
  • Leukemias supervening after other myeloproliferative diseases.
  • Leukemias supervening after overt MDS of less than 6 months duration.
  • Inadequate renal and liver function.
  • Patients with severe heart failure.
  • Patients with severe concomitant neurological disease.
  • Other progressive malignant diseases. However, secondary acute leukemias following cured Hodgkin�s disease or other malignancies will be included, as well as secondary leukemias following other exposure to alkylating agents or radiations for any other reason.
  • Patients already treated for their MDS or AML by intensive chemotherapy, and/or radiotherapy.
  • Patients treated with biological response modifiers and/or low dose Ara-C within 4 weeks prior to entry.

Participating Sites

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Participating Parties

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