NCT01716793

Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Leukemia, Myelocytic, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1998-09-01
• Primary completion: 1998-09-01
• Completion: 2003-11-01
• First posted: 2012-10-30
• Last updated: 2012-11-01

Locations

19 sites across 1 country: Spain