Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3 days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during induction and risk-adapted post remission treatment based on the improvement in prognostic characterization of AML and the implementation of novel transplantation techniques.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Criteria

Inclusion Criteria:

• Patients with newly diagnosed AML, classified by FAB criteria

• Age not superior to 60 years

• Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation

Exclusion Criteria:

• Patients treated previously for its AML with other chemotherapy different from hydroxyurea

• Acute promyelocytic leukemia (M3)

• Chronic myeloid leukemia in blastic crisis

• Leukemias appearing after other myeloproliferative processes

• Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution

• Presence of other neoplastic disease in activity

• Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation

• Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia

• Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both

• Patients with a grave concomitant neurological or psychiatric disease

• Positivity of HIV (donor and/or receptor)