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Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

NCT01716793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2012-11-01

No results posted yet for this study

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.

Conditions

  • Leukemia, Myelocytic, Acute

Interventions

DRUG

Ara-C

* Intermediate dose during induction phase to remission. * High-dose during consolidation phase in patients with favorable cytogenetics.

OTHER

Autologous transplantation

* In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission. * In patients with other cytogenetics without HLA-Identical sibling.

OTHER

Allogeneic HLA-identical sibling transplantation

* 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.

OTHER

CD34+ selection

In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.

Sponsors & Collaborators

  • Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-30
Primary Completion
1998-09-30
Completion
2003-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716793 on ClinicalTrials.gov