Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Clofarabine; Cytarabine

Criteria

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.