Clinical trial · Interventional
Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
- 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)
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (idarubicin, cytarabine)
- description
- Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
- interventionNames
- Drug: cytarabine
- Drug: idarubicin
Primary outcomes (1)
- measure
- Complete Remission (CR)
- timeFrame
- 7 days post completion of induction chemotherapy
- description
- The peripheral blood neutrophil count is \>= 1.5 x 10\^9 / L and platelets more than 100 x 10\^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Newly diagnosed acute myeloid leukemia (AML) * Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease * FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease * Previously untreated with radiotherapy or chemotherapy * Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy * Patients with prior myelodysplastic syndrome are eligible * Extramedullary leukemia allowed * AML with lymphoid markers allowed Exclusion criteria: * Blastic transformation of chronic myelogenous leukemia * Biphenotypic leukemia * FAB M3 disease (acute promyelocytic leukemia) PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 weeks * Total bilirubin \< 1.5 g/dL * AST and ALT \< 5 times upper limit of normal (ULN) * Creatinine \< 1.5 mg/dL OR creatinine clearance \> 70 mL/min * Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration * HIV antibody-negative PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics * Prior hydroxyurea or corticosteroids allowed * At least 48 hours since prior and no concurrent itraconazole or fluconazole Exclusion criteria: * More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
References
Publications (0)
Data not yet available