Clinical trial · Interventional
Risk-adapted Therapy for Primary Acute Myeloid Leukemia
Risk-adapted Therapy for Primary Acute Myeloid Leukemia (AML) in Adult Patients up to 70 Years Old
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 patients up to the age of 70 diagnosed with de novo acute myeloid leukemia (AML). Modifications from the previous protocol AML-03 (NCT01723657) include removal of etoposide in induction, limitation of the GCSF priming to the induction phase and categorization of post remission therapy (stem cell transplant or 2 high dose cytarabine consolidations) according to diagnostic genetics as well as post-remission clearance of measurable residual disease. The aims of these modifications are to improve the overall survival and leukemia free survival of acute myeloid leukemia patients with a risk-adapted approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic matched or unrelated donor transplant. | Procedure | — | UNRESOLVED |
| Ara-C | Drug | Cytarabine | ALIAS |
| Autologous peripheral blood stem cell transplant | Procedure | — | UNRESOLVED |
| G-CSF | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Measurable residual disease | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Risk-adapted postremission treatment.
- description
- Induction (idarubicin, cytarabine), first consolidation (high dose cytarabine), risk- stratification: allogeneic matched related or unrelated donor transplant vs. consolidation courses.
- interventionNames
- Drug: Idarubicin
- Drug: Ara-C
- Drug: G-CSF
- Procedure: Allogeneic matched or unrelated donor transplant.
- Procedure: Autologous peripheral blood stem cell transplant
- Procedure: Measurable residual disease
Primary outcomes (3)
- measure
- Complete remission rate (CRR)
- timeFrame
- 2 months
- description
- Analyze the efficacy and toxicity of the current doses of IC (Idarubicin and cytarabine) with G-CSF priming to achieve complete remission in patients tih AML up to 70yo.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed AML, classified using the World Health Organization (WHO) 2017 criteria. * Patients with 70 years old or younger. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDOnate G, Pratcorona M, Garrido A, Artigas-Baleri A, Bataller A, Tormo M, Arnan M, Vives S, Coll R, Salamero O, Vall-Llovera F, Sampol A, Garcia A, Cervera M, Avila SG, Bargay J, Ortin X, Nomdedeu JF, Esteve J, Sierra J; Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias (CETLAM). Survival improvement of patients with FLT3 mutated acute myeloid leukemia: results from a prospective 9 years cohort. Blood Cancer J. 2023 May 5;13(1):69. doi: 10.1038/s41408-023-00839-1. PMID 37147301