Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy.
18 Years
70 Years
Both
Di Novo Acute Myeloid Leukemia
Trial Information
Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy.
Inclusion Criteria:
Informed consent signature Patients with newly diagnosed AML, classified according to WHO
criteria. Age more than or equal to 18 and less than or equal to 70 years.
Exclusion Criteria:
Patients previously treated with chemotherapy for their AML other than hydroxyurea.
Acute promyelocytic leukemia with t (15; 17). Blast crisis of chronic myeloid leukemia.
Leukemias that appear after other myeloproliferative neoplasms. Leukemias ensuing
myelodysplastic syndromes after more than 6 months. Presence of other malignancies in
activity. AML secondary to chemo-radiotherapy treatment for other malignancies. Abnormal
renal and hepatic function, with creatinine value and / or bilirubin 2 times the normal
limit value, except where the alterations are attributable to leukemia.
Patients with markedly reduced ejection fraction (less than 45%), symptomatic heart
failure, or both of the normal value of the center.
Patients with serious concomitant psychiatric or neurological disease. HIV-positive.
Pregnancy or breastfeeding
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of complete remissions (CR)
Outcome Description:
Identify the highest dose of idarubicin in combination with cytarabine and G-CSF that produces a CR rate equal to or greater than 65% with tolerable toxicity.
Outcome Time Frame:
From 28 up to 56 days after first induction
Safety Issue:
No
Principal Investigator
Salut Brunet, 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:
IIBSP-CSF-2011-141
NCT ID:
NCT01700413
Start Date:
October 2012
Completion Date:
December 2013
Related Keywords:
- Di Novo Acute Myeloid Leukemia
- acute
- myeloid
- leukemia
- CETLAM
- Idarubicin
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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