Clinical trial · Interventional
S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
- 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 cyclosporine, daunorubicin, and cytarabine, 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: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| 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
- Complete remission (CR)
- timeFrame
- After induction therapy is completed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Morphologically confirmed acute myeloid leukemia (AML)
* Differential diagnosis of AML based on FAB classification system
* M0-M7 (No M3)
* No blastic transformation of chronic myelogenous leukemia
* Must be currently registered on protocols SWOG-9007 and SWOG-S9910
PATIENT CHARACTERISTICS:
Age
* 56 and over
Performance status
* Zubrod 0-3 (for patients 56 to 60 years of age) OR
* Zubrod 0-2 (for patients 61 to 70 years of age) OR
* Zubrod 0-1 (for patients 71 years of age and over)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
* AST and/or ALT no greater than 4 times ULN
Renal
* Creatinine no greater than 1.5 times ULN AND/OR
* Creatinine clearance greater than 40 mL/min
Cardiovascular
* Left ventricular function normal
* Ejection fraction at least 50% by MUGA or echocardiogram
* No unstable cardiac arrhythmias
* No unstable angina
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent pegfilgrastim
Chemotherapy
* At least 30 days since prior low-dose cytarabine (less than 100 mg/m\^2/day) for myelodysplastic syndromes and recovered
* Prior hydroxyurea to control high cell counts allowed
* No prior systemic chemotherapy for acute leukemia
* Concurrent single-dose intrathecal chemotherapy allowed
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available