Clinical trial · Interventional
Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
- 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)
In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3 days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during induction and risk-adapted post remission treatment based on the improvement in prognostic characterization of AML and the implementation of novel transplantation techniques.
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, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic HLA-identical sibling transplantation | Other | — | UNRESOLVED |
| Ara-C | Drug | Cytarabine | ALIAS |
| Autologous transplantation | Other | — | UNRESOLVED |
| CD34+ selection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Risk-adapted postremission treatment
- description
- Ara-C, autologous transplantation, Allogeneic HLA-identical sibling transplantation depending on risk factors (cytogenetics, courses to CR)and availability of an HLA-identical sibling, CD34+ selection.
- interventionNames
- Drug: Ara-C
- Other: Autologous transplantation
- Other: Allogeneic HLA-identical sibling transplantation
- Other: CD34+ selection
Primary outcomes (2)
- measure
- Complete remission rate.
- timeFrame
- 2 months.
- description
- Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
- measure
- Disease free survival.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed AML, classified by FAB criteria * Age not superior to 60 years * Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation Exclusion Criteria: * Patients treated previously for its AML with other chemotherapy different from hydroxyurea * Acute promyelocytic leukemia (M3) * Chronic myeloid leukemia in blastic crisis * Leukemias appearing after other myeloproliferative processes * Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution * Presence of other neoplastic disease in activity * Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation * Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia * Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both * Patients with a grave concomitant neurological or psychiatric disease * Positivity of HIV (donor and/or receptor)
References
Publications (0)
Data not yet available