NCT00334074

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 objective is to determine the overall response rate (complete response \[CR\] plus partial response \[PR\]); secondary objective of this study is to characterize and quantify the toxicity profile associated with clofarabine plus cytarabine treatment. A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days of clofarabine intra venous infusion (IVI) followed 4 hours later by cytarabine IVI.Patients will receive up to a maximum of 4 cycles of study treatment. Next cycle will start approximately 4 weeks after Day 1 of previous cycle.No other investigational or commercial agents including chemotherapy, radiotherapy, or immunotherapy may be administered to patients enrolled in this study with the intention of treating the underlying malignancy Patients will remain on study, and be monitored until 4 months have elapsed from the beginning date of their last cycle of treatment.

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndromes
• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Clofarabine and Cytarabine	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

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-02-01
• Completion: 2008-02-01
• First posted: 2006-06-06
• Last updated: 2013-07-17
• Results posted: 2013-07-17

Locations

1 site across 1 country: United States