Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in Elderly Patients
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.
The patients eligible for enrollment must be >18 years and have standard or poor cytogenetic
risk AML in first relapse or primary refractory status or untreated high-risk (>10% blasts)
MDS or chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing
imatinib therapy or selected elderly patients with untreated AML who are at high risk of
anthracycline toxicity. Excluded are FAB M3 AML, patients eligible for allogeneic
transplant(availability of the donor and appropriate performance status and organ
functions).
A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days
of clofarabine IVI followed 4 hours later by cytarabine IVI. Next cycle will start
approximately 4 weeks after Day 1 of previous cycle.
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete response [CR] plus partial response [PR])
Four months after the last dose of study drug
No
Edward Agura, MD
Principal Investigator
Baylor University Medical Center - Director Blood and Marrow Transplantation Services
United States: Food and Drug Administration
004-145
NCT00334074
September 2004
April 2008
Name | Location |
---|---|
Baylor University Medical Center | Dallas, Texas 75246 |