Clinical trial · Interventional
Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
A Phase I Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
- 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 cytarabine and clofarabine, 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 I trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic 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 |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response rate
- measure
- Safety profile and tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) * No M3 AML * Meets 1 of the following criteria: * In first relapse * In second relapse after a second complete remission (CR) that lasted ≥ 3 months * Refractory to initial induction therapy * No symptomatic CNS involvement PATIENT CHARACTERISTICS: * ECOG performance status ≤ 2 * Creatinine \< 2 mg/dL * Bilirubin ≤ 2 mg/dL * AST and ALT ≤ 4 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 weeks after completing study treatment * Ejection fraction ≥ 45% by echocardiogram * No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant * No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures * No other severe concurrent disease that would preclude study treatment PRIOR CONCURRENT THERAPY: * At least 1 week since prior therapy and recovered * No other concurrent chemotherapy * Hydroxyurea to control WBC count before starting study treatment allowed * No concurrent corticosteroids unless used for diseases other than leukemia * No concurrent palliative radiotherapy * No concurrent growth factors (e.g., epoetin alfa, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\]) in patients with AML
References
Publications (0)
Data not yet available