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Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed 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 Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia Clinical research trials and Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed 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 Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia. Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed 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 Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed 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 > Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia  Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
For Condition: chronic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): Medical Research Council , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase.
Details: OBJECTIVES: I. Compare overall survival in patients with chronic myelogenous leukemia in chronic phase treated with interferon alfa with or without cytarabine vs autologous peripheral blood stem cell transplantation followed by interferon alfa with or without cytarabine. II. Compare the time to blast transformation with these treatment regimens in these patients. III. Compare the number of these patients reverting to Philadelphia chromosome (Ph) negative hematopoiesis with these treatment regimens. IV. Compare the complete and major cytogenetic response rates in these patients at one year after receiving these treatment regimens and annually thereafter. V. Compare the hematological remission rate in these patients after receiving these treatment regimens. VI. Compare the duration of hematological remission and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VII. Compare the duration of Ph negative hemapoiesis and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VIII. Determine the number of these patients who fail one treatment regimen and can be rescued with the alternative. IX. Compare quality of life in these patients with these treatment regimens. X. Determine the number of these patients who tolerate these two regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo mobilization chemotherapy with a regimen of the center's choice, such as either of the following: Patients receive idarubicin IV over 10 minutes, etoposide IV over 2 hours, and cytarabine IV over 2 hours on days 1-3; and filgrastim (G-CSF) subcutaneously (SC) starting day 11 and continuing until blood counts recover. OR Patients receive hydroxyurea IV daily until the neutrophil count drops below 1,000/mm3 or the platelet count drops below 20,000/mm3 followed by G-CSF SC for 3 consecutive days or until leukapheresis is complete. Following mobilization therapy, patients undergo leukapheresis within 6 months of diagnosis. Patients then undergo cytoreductive therapy consisting of oral busulfan on days -5 to -2. Autologous peripheral blood stem cells are infused on day 0. Once blood counts have recovered, patients receive interferon alfa SC 3 times a week for 8 weeks, and then daily for at least a total of 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine SC once a day for 10 days each month, beginning 2 weeks after the interferon alfa therapy begins and continuing until complete cytogenetic response is achieved. Arm II: Patients receive interferon alfa SC 3 times a week for 4 weeks, and then daily for 6 months. If hematological remission is achieved after 6 months, interferon treatment is continued for at least another 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine as in arm I. Quality of life is assessed at defined intervals. Patients are followed for at least 2 years. PROJECTED ACCRUAL: Approximately 744 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed chronic myelogenous leukemia in chronic phase; Philadelphia chromosome and/or BCR/ABL positive; Initial diagnosis within 6 months of randomization - No clinical or laboratory evidence of acceleration or blastic disease - No contraindication to peripheral blood cell stem cell collection prior to treatment --Prior/Concurrent Therapy-- - Biologic therapy: No prior interferon alfa - Chemotherapy: Prior hydroxyurea allowed - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 15 to 65 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No major organ impairment; Not pregnant; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanFranklin, Study Chair, Medical Research Council
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Royal Infirmary
Glasgow, Scotland, G4 0SF
United Kingdom
Additional Information:
Study ID Numbers: CDR0000065146; MRC-LEUK-CML-2000,EU-96029,MRC-LEUK-CML-IV,MRC-LEUK-CML-IVa
Study Start Date: January 1996
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002868
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
2. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
3. Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
4. Interferon alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
5. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
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