Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
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.
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Drug: Clofarabine and Cytarabine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity [ Time Frame: Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study. ] [ Designated as safety issue: No ]
Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia:
Complete Response (CR) was defined as normalization of marrow blasts (< 5%), recovery of normal heamtopoiesis (absolute neutrophil count >1 X 10^9/l, platelet count ≥100 X10^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support.
Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts.
Treatment failure was defined as a <25% change in marrow blasts within 30 days of starting therapy
- Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine [ Time Frame: Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug ] [ Designated as safety issue: Yes ]Patients will be monitored clinically and diagnostically using measures including blood test, bone marrow aspiration and MUGA. Toxicity assessment every week using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be performed.
|Study Start Date:||August 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Experimental: Clofarabine and Cytarabine
Five consecutive days of clofarabine 40 mg/m^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m^2 IVI over 2 hours
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
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.
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Edward Agura, MD||Baylor University Medical Center - Director Blood and Marrow Transplantation Services|