Leukemia, Myelocytic, Acute Clinical Trial
Official title:
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
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.
Status | Completed |
Enrollment | 354 |
Est. completion date | November 2003 |
Est. primary completion date | September 1998 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital A Coruña | A Coruña | Coruña |
Spain | Hospital Germans Trias i Pujol | Badalona | Barcelona |
Spain | Centro Medico Teknon | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Jordi Esteve | Barcelona | |
Spain | Hopital Universitari de Girona Dr. Josep Trueta | Girona | |
Spain | ICO Hospital Universitari de Bellvitge | L'Hospitalet del Llobregat | Barcelona |
Spain | Hospital Universitari Arnau de Vilanova | Lleida | |
Spain | Hospital Universitario Virgen de la Victoria | Malaga | |
Spain | Hospital General Universitario de Murcia | Murcia | |
Spain | Hospital Universitari Son Espases | Palma de Mallorca | Mallorca |
Spain | Joan Bargay | Palma de Mallorca | Mallorca |
Spain | Hospital Universitari Joan XXIII | Tarragona | |
Spain | Mutua de Terrassa | Terrassa | |
Spain | Hospital Verge de la Cinta | Tortosa | Tarragona |
Spain | Hospital Clínico Universitario de Valencia | Valencia | |
Spain | Hospital Universitario Rio Hortega | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission rate. | Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission. | 2 months. | Yes |
Primary | Disease free survival. | Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors. | 4 years. | No |
Secondary | Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment. | Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up. | 4 years. | No |
Secondary | Feasibility to mobilize and collect autologous PBSC after consolidation phase. | Evaluation of mobilization failures. | 6 months. | No |
Secondary | Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome. | CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up. | 4 years. | Yes |
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