Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
1 other identifier
interventional
354
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 1998
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedNovember 1, 2012
October 1, 2012
Same day
October 22, 2012
October 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (3)
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.
Study Arms (1)
Risk-adapted postremission treatment
OTHERAra-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.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 30, 2012
Study Start
September 1, 1998
Primary Completion
September 1, 1998
Study Completion
November 1, 2003
Last Updated
November 1, 2012
Record last verified: 2012-10