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Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
ClinicalTrials.gov Identifier:
NCT01716793
First received: October 22, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes

October 22, 2012
October 31, 2012
September 1998
September 1998   (final data collection date for primary outcome measure)
  • Complete remission rate. [ Time Frame: 2 months. ] [ Designated as safety issue: Yes ]
    Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
  • Disease free survival. [ Time Frame: 4 years. ] [ Designated as safety issue: No ]
    Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.
  • Complete remission rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve CR
  • Disease free survival. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Analyze the disease free survival of patients in remission, with a therapeutic strategy adjusted to the prognostic factors
Complete list of historical versions of study NCT01716793 on ClinicalTrials.gov Archive Site
  • Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment. [ Time Frame: 4 years. ] [ Designated as safety issue: No ]
    Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.
  • Feasibility to mobilize and collect autologous PBSC after consolidation phase. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
    Evaluation of mobilization failures.
  • Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome. [ Time Frame: 4 years. ] [ Designated as safety issue: Yes ]
    CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up.
  • Evalutations of minimal residual disease (MRD) by flow cytometry during and after treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Study of the immunophenotipic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.
  • Feasibility to mobilize and collect autologous PBSC after consolidation phase. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evalutaion of mobilization failures.
  • Evaluations of the CD34+ cell selection procedure and allogeneic PSCT transplantation outcome [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    C34+ cell selectionf rom PBSC of HLA-identical siblings. Conditioning regimen. Infusion and postransplant follow-up.
Not Provided
Not Provided
 
Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myelocytic, Acute
  • 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.
Risk-adapted postremission treatment
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.
Interventions:
  • Drug: Ara-C
  • Other: Autologous transplantation
  • Other: Allogeneic HLA-identical sibling transplantation
  • Other: CD34+ selection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
November 2003
September 1998   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01716793
AML-99
Yes
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Not Provided
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
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP