Treatment of de Novo Acute Myeloid Leukemia With the Combination of Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin (Mylotarg ®), Associated or Not Priming With G-CSF. Prospective Study of Efficacy and Toxicity
18 Years
70 Years
Both
Novo Acute Myeloid Leukemia
Trial Information
Treatment of de Novo Acute Myeloid Leukemia With the Combination of Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin (Mylotarg ®), Associated or Not Priming With G-CSF. Prospective Study of Efficacy and Toxicity
Inclusion Criteria:
1. Patients with primary or "de novo" AML, different than promyelocytic or M3 subtype.
2. Age 18 to 70 years.
3. Written informed consent form
Exclusion Criteria:
1. Acute leukemia appeared after a myeloproliferative process or a myelodysplastic
syndrome longer than 6 months, AML arising after another cured malignant disease
(e.g. Hodgkin's disease), and secondary AML treated with alkylating agents or
radiation.
2. Acute promyelocytic leukemia.
3. Relevant history of liver disease. Significant impaired liver function (bilirubin,
AST or ALT ≥ 2.5 times the normal value) not attributable to leukemic infiltration.
4. Patients with prior heart failure.
5. Symptomatic chronic respiratory failure.
6. Positive serology for HIV, hepatitis C virus or its surface antigen.
7. Estimated life expectancy less than 3 months, despite treatment.
8. Pregnancy or breastfeeding at the time of inclusion in the study.
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 of the Disease
Outcome Description:
Bone marrow normocellular or slightly hypocellular with proportion of blasts <5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission
Outcome Time Frame:
28 days after chemotherapy
Safety Issue:
No
Principal Investigator
Jordi Sierra, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Authority:
Spain: Spanish Agency of Medicines
Study ID:
ICOG-07
NCT ID:
NCT01698879
Start Date:
October 2009
Completion Date:
February 2013
Related Keywords:
- Novo Acute Myeloid Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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