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.
Induction chemotherapy: idarubicin (12mg/m2/day intravenous), intermediate-dose cytarabine (500mg/m2/12h, intravenous) and etoposide (100mg/m2/day, intravenous) in 3+7+3 schedule. This induction therapy is repeated if complete remission (CR) is not achieved after the first course of treatment. Consolidation therapy: mitoxantrone (12mg/m2/day, intravenous, days 4, 5 and 6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6). Risk-stratification according to cytogenetics, courses to CR and availability of an HLA-identical sibling: * Patients in the favorable cytogenetics group \[t(8;21), inv(16) or t(16;16)\] are treated with high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5). * Patients in intermediate cytogenetics group (normal karyotype and a single course to achieve the CR) receive an autologous peripheral blood stem cell (PBSC) transplant, regardless of having an HLA-identical sibling. * The remaining patients are considered in the high-risk group and are treated with autologous or allogeneic PBSC transplantation depending on the availability of a sibling donor. In allotransplants, CD34+ cell selection of hematopoietic cells is performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
354
* Intermediate dose during induction phase to remission. * High-dose during consolidation phase in patients with favorable cytogenetics.
* In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission. * In patients with other cytogenetics without HLA-Identical sibling.
* Patients without favorable or normal karyotype(and one course to CR). * Patients with normal karyotype who need two cycles of chemotherapy to achieve CR, and other cytogenetics.
In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Centro Medico Teknon
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Jordi Esteve
Barcelona, Barcelona, Spain
ICO Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital A Coruña
A Coruña, Coruña, Spain
Hopital Universitari de Girona Dr. Josep Trueta
Girona, Girona, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
...and 9 more locations
Complete remission rate.
Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
Time frame: 2 months.
Disease free survival.
Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.
Time frame: 4 years.
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.
Time frame: 4 years.
Feasibility to mobilize and collect autologous PBSC after consolidation phase.
Evaluation of mobilization failures.
Time frame: 6 months.
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.
Time frame: 4 years.
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