Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01716793
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2012-10-22
Brief Title:
Risk-adapted Therapy for Adult Acute Myeloid Leukemia
Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Organization:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Study Overview
Official Title:
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 3 days plus conventional dose cytarabine 100mgm2day in continuous infusion during 7 days and etoposide 100mgm2 IVday 3 days If idarubicin 10 mgm2 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 12mgm2day intravenous intermediate-dose cytarabine 500mgm212h intravenous and etoposide 100mgm2day intravenous in 373 schedule This induction therapy is repeated if complete remission CR is not achieved after the first course of treatment
Consolidation therapy mitoxantrone 12mgm2day intravenous days 4 5 and 6 and intermediate-dose cytarabine 500mgm212h 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 t821 inv16 or t1616 are treated with high-dose cytarabine 3gm212h 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
Consolidation therapy mitoxantrone 12mgm2day intravenous days 4 5 and 6 and intermediate-dose cytarabine 500mgm212h 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 t821 inv16 or t1616 are treated with high-dose cytarabine 3gm212h 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None