Clinical trial · Interventional
Lomustine and Intermediate Dose Cytarabine in Older Patients With AML
Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia
- 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)
A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lomustine, intermediate dose cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary Outcomes: The primary objective of this study was to assess the ability of lomustine to increase the CR rate and to improve overall survival
- timeFrame
- 13 months
Secondary outcomes (1)
- measure
- Secondary Outcomes: The secondary objective was to test intermediate-dose cytarabine on survival, and to analyze the impact of prognostic factors on CR and survival.
- timeFrame
- 13 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 60 years and older with de novo AML according to FAB criteria * With normal cardiac function with left ventricular ejection fraction \>= 50%, absence of unstable cardiac arrhythmia or unstable angina. * Unimpaired renal (creatinin \<180µmol\\L) * Unimpaired liver (bilirubin \<35µmol\\L) functions. * Performance status \<3 * Signed and dated informed consent. Exclusion Criteria: * Acute promyelocytic leukemia * Patients with myeloproliferative syndromes prior to diagnosis of AML * Patients who previously had myelodysplastic syndrome * Patients pretreated with chemo- or radiotherapy * Performance status \<2 * Positive serology for HIV
References
Publications (0)
Data not yet available