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Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716793
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Drug: Ara-C Other: Autologous transplantation Other: Allogeneic HLA-identical sibling transplantation Other: CD34+ selection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
Study Start Date : September 1998
Actual Primary Completion Date : September 1998
Actual Study Completion Date : November 2003

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Complete remission rate. [ Time Frame: 2 months. ]
    Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.

  2. Disease free survival. [ Time Frame: 4 years. ]
    Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.

Secondary Outcome Measures :
  1. Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment. [ Time Frame: 4 years. ]
    Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.

  2. Feasibility to mobilize and collect autologous PBSC after consolidation phase. [ Time Frame: 6 months. ]
    Evaluation of mobilization failures.

  3. Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome. [ Time Frame: 4 years. ]
    CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716793

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Sponsors and Collaborators
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
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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
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Responsible Party: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias Identifier: NCT01716793    
Other Study ID Numbers: AML-99
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias:
Primary AML
Risk-adapted treatment
Hematopoietic transplantation
CD34+ cell selection
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type