Status:
COMPLETED
Risk-adapted Therapy for Primary Acute Myeloid Leukemia
Lead Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
17-70 years
Phase:
PHASE2
Brief Summary
The AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy with idarubicin and cytarabine (IC) with G-CSF priming followed by a risk-adapted post remission therapy for ...
Detailed Description
Induction chemotherapy: Idarubicin (12mg/m2/day intravenous, days 1-3), Low-dose cytarabine (200mg/m2/day, intravenous in continuous infusion, days 1-7) and G-CSF priming 150mcg/m2/day, subcutaneous f...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed AML, classified using the World Health Organization (WHO) 2017 criteria.
- Patients with 70 years old or younger.
Exclusion
- Patients previously treated for the AML with chemotherapy different from hydroxyurea.
- Acute promyelocytic leukemia with t(15;17).
- Chronic myeloid leukemia in blastic phase.
- Secondary AML or therapy related AML.
- Presence of concomitant active neoplastic disease.
- Abnormal renal and hepatic functions with creatinin and/or bilirubin 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia.
- Patients with a cardiac ejection fraction below 45%, symptomatic cardiac deficiency or both.
- Patients with neurological or concomitant psychiatric disease.
- HIV infection.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
1034 Patients enrolled
Trial Details
Trial ID
NCT04687098
Start Date
February 1 2012
End Date
November 10 2022
Last Update
June 27 2023
Active Locations (15)
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1
ICO Badalona-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
ICO Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, Spain, 07198
4
Hospital Universitari Son Llatzer
Palma de Mallorca, Mallorca, Spain