Clinical trial · Interventional
Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
A Phase II Study of Clofarabine and Cytarabine for Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Persistent Disease After Treatment With an Anthracycline and Cytarabine
NCT01960387CI-TRIAL-00023334UPCI 13-066terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patients with persistent AML after treatment with an anthracycline and cytarabine.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine and Cytarabine
- description
- Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5. Cytarabine at a dose of 1g/m2 daily will then be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.
- interventionNames
- Drug: Clofarabine
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Complete Clinical Response
- timeFrame
- Between 14 and 28 days from start of study treatment
- description
- Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10\^9/l, a platelet count greater than or equal to 100 x 10\^9/l, and no evidence of extramedullary disease.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly diagnosed AML based on the World Health Organization classification who have persistent disease after their first course treatment with an anthracycline and cytarabine 2. Able to understand and have the ability to provide written informed consent 3. Patients over 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Left ventricular ejection fraction (LVEF) ≥ 50% 6. Negative urine pregnancy test for all females 7. All subjects must agree to use an effective method of contraception while receiving the study drugs Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia 2. Relapsed AML 3. Prior use of clofarabine 4. Previous allogeneic or autologous hematopoietic cell transplantation 5. Impaired liver function (serum total bilirubin \> 2.0 mg/dL, alanine aminotransferase and aspartate aminotransferase ≥ 4 x the upper limit of normal) 6. Impaired renal function (serum creatinine ≥ 2.0 mg/dL) 7. Uncontrolled or life-threatening infection that is not responding to antimicrobial therapy 8. History of a psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent 9. Concurrent active malignancy; exceptions include patients who have been disease free for 5 years, patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or patients with another malignancy that is indolent or definitively treated 10. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory or cardiac disease)
References
Publications (0)
Data not yet available
No reference posted for this study.