Clinical trial · Interventional
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in Selected Elderly Patients at High Risk of Anthracycline Toxicity
NCT00334074CI-TRIAL-00011379completedPhase 2Results postedClinicalTrials.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)
The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS.
Conditions
Conditions (3)
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine and Cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine and Cytarabine
- description
- Five consecutive days of clofarabine 40 mg/m\^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m\^2 IVI over 2 hours
- interventionNames
- Drug: Clofarabine and Cytarabine
Primary outcomes (1)
- measure
- Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity
- timeFrame
- Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.
- description
- Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia: Complete Response (CR) was defined as normalization of marrow blasts (\< 5%), recovery of normal heamtopoiesis (absolute neutrophil count \>1 X 10\^9/l, platelet count ≥100 X10\^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support. Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts. Treatment failure was defined as a \<25% change in marrow blasts within 30 days of starting therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Adult patients who are at least 18 years old with histologically confirmed disease as follows: * Standard or poor cytogenetic risk acute myelogenous leukemia (AML) according to the Southwestern Oncology Group (SWOG) criteria in first relapse or primary refractory status * Untreated high-risk myelodysplastic syndrome (MDS) defined as \>10% blasts * Chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing imatinib therapy. * Selected elderly patients with untreated AML who are at high risk of anthracycline toxicity. Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or * Laboratory values obtained less than or equal to 7 days prior to receiving study treatment: * Total bilirubin \< 2.0 mg/dL unless elevated due to hemolysis * Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 5 × upper limit of normal (ULN) * Serum creatinine \< 2.0 mg/dL * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: * Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide. * Patients eligible to receive curative allogeneic transplant as determined by performance status, organ function, availability of a matched donor, etc. * Current concomitant chemotherapy, radiation therapy, or immunotherapy. * Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy. * Active heart disease including myocardial infarction within the preceding 3 months. * History of severe coronary artery disease, arrhythmias other than atrial flutter or fibrillation requiring medication, or uncontrolled congestive heart failure * Dyspnea at rest or with minimal exertion. * Patients with an active, uncontrolled systemic infection considered to be opportunistic, life-threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy). * Pregnant or lactating patients. * Prior enrollment in this trial. * Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
References
Publications (0)
Data not yet available
No reference posted for this study.