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Interferon alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia



Interferon alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,Philadelphia chromosome negative chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Low doses of interferon alfa may be as effective as high doses. PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose or high-dose interferon alfa in treating patients who have newly diagnosed chronic myelogenous leukemia.
Details: OBJECTIVES: I. Compare the duration of chronic phase and survival following low- vs. high-dose interferon alfa maintenance therapy in patients with chronic myelogenous leukemia in chronic phase. II. Compare the toxicity profiles, assessed by WHO criteria, and the percentage of patients requiring dose reduction or discontinuation with these two regimens. III. Compare hematologic and cytogenetic responses every 6 months in patients treated on these two regimens. PROTOCOL OUTLINE: This is a randomized study. Patients receive daily hydroxyurea until their white blood cell count (WBC) is maintained at a normal level for 2-3 weeks. Patients are randomized to two groups: one group receives daily high-dose interferon alfa, and the other receives low-dose interferon alfa, 5 days per week. Both groups continue to receive hydroxyurea at reduced doses as needed to maintain a normal WBC. Treatment continues until disease progression occurs. Patients may receive cytarabine in addition to interferon in either treatment arm at the investigator's discretion. Cytarabine is given subcutaneously for 10 days every calendar month and continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: Approximately 800 patients will be enrolled over 8 years on this multicenter study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Chronic myelogenous leukemia in chronic phase; Molecular evidence of BCR/ABL rearrangement OR Presence of Philadelphia chromosome - Eligibility for allogeneic bone marrow transplantation does not exclude --Prior/Concurrent Therapy-- - No prior therapy; Prior therapeutic or back-up leukapheresis allowed; Hydroxyurea may be started up to 4 weeks prior to entry --Patient Characteristics-- - Age: Adult - Performance status: WHO 0-2 - Hematopoietic: Not specified - Hepatic: Bilirubin less than twice normal; No severe hepatic problem - Renal: Creatinine less than twice normal; No severe renal problem - Cardiovascular: No severe cardiovascular problem - Other: No contraindication to interferon therapy; No history of severe depression; No pregnant women; Effective contraception required of fertile women
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatriciaShepherd,  Study Chair,  Medical Research Council

Western General Hospital
Edinburgh,  Scotland,  EH4 2XU
United Kingdom
 


Additional Information:
Study ID Numbers:  CDR0000065147;  MRC-LEUK-CML-V,EU-96028
Study Start Date: April 1995
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002869

Other Philadelphia Chromosome Negative Chronic Myelogenous Leukemia Studies:
1. Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

2. Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

3. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia

4. Interferon alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

5. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

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