Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.
18 Years
70 Years
Both
Leukemia, Myelocytic, Acute
Trial Information
Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.
Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5),
intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide
(100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the
addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction
therapy is repeated if complete remission (CR) is not achieved after the first course of
treatment.
Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4
to 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)] and
Leukocyte index <20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone
marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h,
intravenous, days 1, 3 and 5), but in case of LI>20 at diagnosis the intention is to
perform an autologous peripheral blood stem cell (PBSC) transplantation.
- Patients in intermediate risk group, with normal karyotype, a single course of
induction chemotherapy to achieve the CR, the absence of adverse molecular features
(FLT3-ITD or MLL-PTD) and low minimal residual disease levels after consolidation
(MRD<0,1%) receive an autologous PBSC transplant, regardless of having an HLA-identical
sibling.
- The remaining patients defined as high-risk patients are treated with an allogeneic
stem cell transplantation. Depending on the age, if the patient has an HLA-identical
sibling donor, up to age of 50 years old it is performed with conventional conditioning
therapy and positive selection of CD34+, older patients receive a reduced intensity
conditioning regimen.
- Very high risk patients without a sibling are allocated to unrelated donor (9-10/10).
Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received
Mylotarg™ as "in vivo purging" followed by an autologous PBSC transplantation.
Inclusion Criteria:
- Patients with newly diagnosed AML, classified using OMS criteria.
- Patients with 70 years old or younger.
Exclusion Criteria:
- Patients previously treated for the AML with chemotherapy different from hidroxiurea.
- Acute promyelocytic leukemia with t(15;17).
- Cronic mieloid leukemia in blastic crisis.
- Leukemias that appear after other myeloproliferative processes.
- Leukemias that survive after myelodysplasic syndromes of more than 6 months of
evolution.
- Presence of other neoplasic disease in activity.
- Secondary AML which appears after cured malignant disease (for instance, Hodgking
disease), and those who are still exposed to alkilant agents or radiation.
- Abnormal renal and hepatic functions with creatinin and/or bilirrubine 2 times higher
than the normal threshold, except when the alteration should be attributed to the
leukemia.
- Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.
- Patients with neurological or concomitant psychiatric disease.
- Positivity by HIV.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission rate (CRR)
Outcome Description:
Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.
Outcome Time Frame:
2 months.
Safety Issue:
Yes
Principal Investigator
Jorge Sierra, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Authority:
Spain: Departament de Salut de la Generalitat de Catalunya
Study ID:
AML-03
NCT ID:
NCT01723657
Start Date:
October 2003
Completion Date:
March 2012
Related Keywords:
- Leukemia, Myelocytic, Acute
- Leukemia
- Myeloid
- Acute
- Young
- CETLAM
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Neoplasm, Residual
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