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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

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

Clofarabine and Cytarabine

Edward Agura, MD

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.

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.

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

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

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.

Baylor Research Institute

Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.

Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Edward Agura

Overall Response Rate

Complete Response

Partial Response

Not Responding

Not evaluable

Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.

Clofarabine Plus Cytarabine

Intent to Treat analysis; per eligible participants enrolled in the study.

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

Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine

5 consecutive days of Clofarabine 40 mg/m\^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m\^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS	NCT00334074	Acute Myelogeno... Myelodysplastic... Chronic Myeloge...	Clofarabine and...	18 Years - 85 Years	Baylor Research Institute
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS	NCT00334074	Acute Myelogeno... Myelodysplastic... Chronic Myeloge...	Clofarabine and...	18 Years - 85 Years	Baylor Research Institute

Spots Global Cancer Trial Database for elderly aml patients with risk of anthracycline toxicity