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

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

= Active hospitals

= Inactive hospitals