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Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome Clinical research trials and Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 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 Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome clinical trial. Subjects frequently obtain the most expert healthcare possible for their Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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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. Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
2. Reduced-Intensity Regimen Before Donor Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndromes
3. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
4. Blood and Marrow Transplant Clinical Research Network
5. A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
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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