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Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Clinical research trials and Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia. Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia  Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Not yet recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies, such as PEG-interferon alfa-2a, may interfere with the growth of cancer cells and slow the growth of cancer. It is not yet known whether imatinib mesylate is more effective given in higher doses or combined with either cytarabine or PEG-interferon alfa-2a in treating chronic phase chronic myelogenous leukemia. PURPOSE: Randomizedphase II trial to compare the effectiveness of imatinib mesylate with or without cytarabine or PEG-interferon alfa-2a in treating patients who have previously untreated chronic phase chronic myelogenous leukemia.
Details: OBJECTIVES: - Compare the rate of molecular response, as measured by the decrease in bcr-abl transcripts after 12 months of treatment, in patients with previously untreated chronic phase chronic myelogenous leukemia treated with imatinib mesylate at standard vs increased dose alone vs imatinib mesylate and cytarabine vs imatinib mesylate and PEG-interferon alfa-2a. - Compare rates of cytogenetic and hematologic response in patients treated with these regimens. - Compare, preliminarily, the prognostic effects of der(9) and der(22) chromosomal deletions for response in patients treated with these regimens. - Compare, preliminarily, changes in gene expression at pre-treatment vs at relapse or progression in patients treated with these regimens. - Compare the frequency and severity of the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Hasford risk category (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive oral imatinib mesylate once daily. - Arm II: Patients receive oral imatinib mesylate twice daily. - Arm III: Patients receive oral imatinib mesylate as in arm I. Beginning 6 weeks after the initiation of imatinib mesylate, patients also receive PEG-interferon alfa-2a subcutaneously (SC) once weekly. - Arm IV: Patients receive oral imatinib mesylate as in arm I. Beginning 2 weeks after the initiation of imatinib mesylate, patients also receive cytarabine SC once daily for 14 days. Courses of cytarabine repeat every 28 days. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 1 year. PROJECTED ACCRUAL: A total of 468 patients (117 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic phase chronic myelogenous leukemia (CML) by bone marrow aspiration, biopsy, and peripheral blood counts, meeting criteria for 1 of the following: - Philadelphia chromosome-positive* or presence of the variants of the (9;22) translocation by cytogenetics or fluorescent in situ hybridization - Secondary chromosomal abnormalities (in addition to the Philadelphia chromosome) allowed - bcr-abl positive* by reverse transcription polymerase chain reaction NOTE: *First cytogenetic or molecular analysis performed within the past 180 days to confirm status - Must be enrolled on SWOG-9007 (SWOG institutions only) and SWOG-S9910 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2.0 times upper limit of normal (ULN) - AST or ALT no greater than 2.0 times ULN Renal - Not specified Other - Not pregnant or nursing - Fertile patients must use effective contraception - No history of NCI grade 4 depression or uncontrolled depression - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent anticancer biologic agents Chemotherapy - No prior chemotherapy for peripheral blood stem cell mobilization - Prior collection of unmobilized peripheral blood stem cells allowed - No other concurrent anticancer chemotherapy - Concurrent hydroxyurea and/or anagrelide to control blood counts allowed provided it is only administered during the first 28 days of study therapy and for no more than 28 additional days after study therapy Endocrine therapy - Not specified Radiotherapy - No concurrent anticancer radiotherapy Surgery - More than 28 days since prior major surgery and recovered Other - No prior treatment for CML (except hydroxyurea and/or anagrelide) - No concurrent therapeutic anticoagulation with warfarin - Concurrent therapeutic anticoagulation with low-molecular weight heparin allowed - No other concurrent anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarilynSlovak, , Beckman Research Institute
Additional Information:
Study ID Numbers: CDR0000334588; SWOG-S0325
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070499
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
2. Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
3. Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Allogeneic Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
4. Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
5. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
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Imatinib Mesylate With or Without Cytarabine or PEG-Interferon alfa-2a in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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