Clinical trial · Interventional
Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia
Clofarabine in Combination With a Standard Remission Induction Regimen (AraC and Idarubicin) in Patients 18-60 Years Old With Previously Untreated Intermediate and Bad Risk Acute Myelogenous Leukemia (AML) or High Risk Myelodysplasia (MDS) : a Phase I-II Study of the EORTC-LG and GIMEMA (AML-14A Trial)
- 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 clofarabine, cytarabine, and idarubicin, 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 randomized phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and idarubicin in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk myelodysplasia.
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive idarubicin IV over 5 minutes on days 1, 3, and 5, cytarabine IV continuously on days 1-10, and clofarabine IV over 1 hour on days 2, 4, 6, 8, and 10.
- interventionNames
- Drug: clofarabine
- Drug: cytarabine
- Drug: idarubicin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive idarubicin IV and cytarabine IV as in arm I. Patients also receive clofarabine IV by push injection over 10 minutes on days 2, 4, 6, 8, and 10.
- interventionNames
- Drug: clofarabine
- Drug: cytarabine
- Drug: idarubicin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following by WHO criteria:
* Acute myeloid leukemia (AML) (≥ 20% bone marrow blasts by bone marrow aspiration or biopsy)
* No acute promyelocytic leukemia (M3)
* All cytogenetic groups allowed, except for the following:
* t(15;17)
* t(8;21) or inv(16) AND a WBC count at diagnosis of \< 100,000/μL
* Primary or secondary AML allowed, including AML after myelodysplasia (MDS)
* High-risk MDS (≥ 10% bone marrow blasts by bone marrow aspiration or biopsy)
* No chronic myelogenous leukemia in blast crisis or AML supervening a myeloproliferative disorder
* Previously untreated disease, except for ≤ 14 days of hydroxyurea
* No CNS leukemia
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Serum creatinine ≤ 1.0 mg/dL or glomerular filtration rate \> 60 mL/min
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* ALP ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for ≥ 3 months after completion of study treatment
* No active uncontrolled infection
* No HIV positivity
* No psychological, familial, sociological, or geographical conditions precluding compliance with study treatment or follow up
* No concurrent severe uncontrolled cardiovascular disease (i.e., symptomatic congestive heart failure or symptomatic ischemic heart disease \[NYHA class III-IV\])
* No concurrent malignant disease
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent cytotoxic drugs or experimental therapies (e.g., antiangiogenic drugs, tyrosine kinase inhibitors)References
Publications (0)
Data not yet available