Main info

Identificatie:

HO29 AML / SAKK 30/95

Sponsor:

HOVON

Included patients:

1105

Active sites:

0

(of 35)

35 sites are pending

Title:

Remission Induction Chemotherapy with or without rHuG-CSF (lenograstim) sensitization.
Marrow Ablative Chemotherapy plus Autologous Peripheral Progenitor/Stem Cell Transplantation (PBSCT) versus Chemotherapy.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with newly diagnosed de novo AML.
• Age 15-60 years inclusive.
• Patients have given infomed consent.
• Leucocytosis is not an exclusion criterium, but it will require postponement of G-CSF administration until WBC have declined to 20 x 109/l on chemotherapy.

Exclusion Criteria:

A concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma.

• Previous treatment with chemotherapy.
• Leukemia following from a documented myelodysplasia with a duration of more than 6 months.
• Blastic crisis of chronic myeloid leukemia or leukemia developing from myeloproliferative diseases.
• Renal or liver function abnormalities.
• HIV positive serology.
• Severe cardiac, pulmonary or neurologic disease.

Participating Sites

= Active hospitals

= Inactive hospitals