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Home > "C" Clinical Trials Conditions > Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome  Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
For Condition: Leukemia, Myeloid,Myelodysplastic Syndromes
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center , ILEX Products
Synopsis: The goal of this clinical research study is to learn if clofarabine, when given in combination with ara-C (cytarabine), can help to improve the disease's response to therapy and to increase the duration of response in patients who are 50 years or older with leukemia. The safety of this combination treatment will also be studied.
Details: The treatment of acute myeloid leukemia (AML) in older patients has not improved significantly in recent years when compared with the considerable progress that has been made in younger patients. Hence, new drugs and approaches are needed in this poor-prognosis group of patients with AML. Nucleoside analogs are among the most active antileukemic agents available. Clofarabine was synthesized as a rational extension of the experience with other deoxyadenosine analogs. Clofarabine is converted to the monophosphate form by the enzyme deoxycytidine kinase which represents the major metabolite of clofarabine. Phosphorylation of clofarabine is substantially more efficient than that of other nucleosides such as fludarabine and so is intracellular retention of the triphosphate form of clofarabine. Mechanisms of action include inhibition of DNA synthesis, inhibition of DNA polymerases, and potent inhibition of ribonucleotide reductase (RNR) resulting in depletion of normal nucleotides and increased DNA uptake of the analog. Single agent clofarabine has shown activity in phase I studies in AML and ALL. As a potent inhibitor of RNR, however, clofarabine is ideal to be incorporated into biochemical modulation strategies such as have been tested and validated with fludarabine and ara-C in AML. By combining clofarabine with ara-C, inhibition of RNR by clofarabine will result in a drop of deoxynucleotides causing a decrease in the feedback inhibition of deoxcycytidine kinase which is the rate-limiting step in the synthesis of ara-CTP leading to increased retention of ara-CTP. Therefore, the activity of clofarabine and ara-C in leukemic cells would be complemented by a biochemical synergism between these agents that should result in better clinical efficacy. We have established the safety of the combination in salvage patients with acute leukemias.
Eligibility:
Study Type: Interventional,Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/74 Years
Genders: Both
Protocol Entry Criteria: Inclusion: 1. Previously untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) (> 10% blasts). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or “targeted” therapies are allowed. 2. Age > 50 years to < 74 years (diploid cytogenetics) and < 69 years (abnormal cytogenetics). 3. ECOG performance status = 1 year postmenopausal or surgically sterilized). 7. Patients who are considered to require immediate induction (rapidly rising WBC >/= 50,000 and/or organ involvement as per the assessment of the treating physician) can be treated without final cytogenetic results and pretreatment assessment of cardiac ejection fraction (MUGA or echocardiogram) if by history and physical examination patients have
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
StefanFaderl, Principal Investigator, M.D. Anderson Cancer Center
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID03-0139;
Study Start Date: June 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065143
Other Leukemia, Myeloid Studies:
1. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
2. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
3. Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
4. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
Related Studies:
Other Leukemia, Myeloid Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
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