Clinical trial · Interventional
S0112 Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
A Phase II Study Of Daunomycin And ARA-C, Both Given By Continous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
NCT00023777CI-TRIAL-00017034completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CR
- timeFrame
- After induction therapy is completed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * No M3 AML or blastic transformation of chronic myelogenous leukemia * Must be enrolled on SWOG-9007 and S9910 protocols PATIENT CHARACTERISTICS: Age: * 56 and over Performance status: * Zubrod 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT or SGPT no greater than 4 times ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance greater than 40 mL/min Cardiovascular: * LVEF at least 50% by MUGA scan or 2-dimensional echocardiogram * No unstable cardiac arrhythmias * No unstable angina Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy for acute leukemia * Prior hydroxyurea to control high cell counts allowed * Prior low-dose cytarabine (less than 100 mg/m\^2/day) for treatment of myelodysplastic syndrome allowed * At least 30 days since prior chemotherapy and recovered * Concurrent single-dose intrathecal chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (3)
- BACKGROUNDAppelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2. PMID 16455952
- DERIVEDMedeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19. PMID 25527568
- DERIVEDMedeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28. PMID 24383844