NCT01716793|CompletedPhase 2DMC
Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
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Sponsor study identifier
interventional
354
1 country
19
Study Start
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 1998
Actual (reported)Study Completion
November 2003
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2003
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
September 1998
Actual (reported)November 2003
Actual (reported)October 22, 2012
Actual (reported)October 30, 2012
Actual (reported)Complete remission rate.
Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
2 months.
Disease free survival.
Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.
4 years.
Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment.
4 years.
Feasibility to mobilize and collect autologous PBSC after consolidation phase.
6 months.
Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome.
4 years.
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.
* 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.
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Centro Medico Teknon
Barcelona, Barcelona, 08022, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Jordi Esteve
Barcelona, Barcelona, 08036, Spain
ICO Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Barcelona, 08907, Spain
Jorge Sierra, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Salut Brunet, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
354 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2012
First Posted
October 30, 2012
Study Start
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
IA14 Induction in Young Acute Myeloid Leukemia
A Risk-Oriented Therapeutic Strategy for Adult Acute Myelogenous Leukemia
* 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hospital A Coruña
A Coruña, Coruña, 15006, Spain
Hopital Universitari de Girona Dr. Josep Trueta
Girona, Girona, 17007, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, 25006, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, 07198, Spain
Joan Bargay
Palma de Mallorca, Mallorca, 07198, Spain
Hospital General Universitario de Murcia
Murcia, Murcia, 30008, Spain
Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43007, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, 43517, Spain
Mutua de Terrassa
Terrassa, Terrassa, 08225, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 496010, Spain
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 41010, Spain
Primary Completion
September 1998
Actual (reported)Study Completion
November 2003
Actual (reported)Last Updated
November 1, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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