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

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT00334074

Run by

Baylor Research Institute

People needed

30

Starts

2005-08-01

Expected to finish

2008-02-01

Last updated by the study team

2013-07-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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