Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
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|ClinicalTrials.gov Identifier: NCT01716793|
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : November 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myelocytic, Acute||Drug: Ara-C Other: Autologous transplantation Other: Allogeneic HLA-identical sibling transplantation Other: CD34+ selection||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||September 1998|
|Actual Study Completion Date :||November 2003|
Risk-adapted postremission treatment
Ara-C, autologous transplantation, Allogeneic HLA-identical sibling transplantation depending on risk factors (cytogenetics, courses to CR)and availability of an HLA-identical sibling, CD34+ selection.
Other: Autologous transplantation
Other: Allogeneic HLA-identical sibling transplantation
Other: CD34+ selection
In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.
- Complete remission rate. [ Time Frame: 2 months. ]Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
- Disease free survival. [ Time Frame: 4 years. ]Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.
- Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment. [ Time Frame: 4 years. ]Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.
- Feasibility to mobilize and collect autologous PBSC after consolidation phase. [ Time Frame: 6 months. ]Evaluation of mobilization failures.
- Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome. [ Time Frame: 4 years. ]CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716793
|Principal Investigator:||Jorge Sierra, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|
|Study Chair:||Salut Brunet, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|