Status:
COMPLETED
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Lead Sponsor:
Baylor Research Institute
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS patients showed promising results. This study is done to confirm the findings from previous studies. Primary ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00334074
Start Date
August 1 2005
End Date
February 1 2008
Last Update
July 17 2013
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246