Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
|ClinicalTrials.gov Identifier: NCT00002869|
Recruitment Status : Unknown
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 16, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: recombinant interferon alfa Drug: cytarabine Drug: hydroxyurea||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Official Title:||PROSPECTIVE RANDOMISED STUDY TO COMPARE LOW-DOSE INTERFERON-ALPHA-n1 (WELLFERON) +/- HYDROXYUREA VS HIGH-DOSE INTERFERON-ALPHA-n1 (WELLFERON) +/- HYDROXYUREA IN PATIENTS WITH NEWLY DIAGONISED CHRONIC PHASE CHRONIC MYELOID LEUKAEMIA|
|Study Start Date :||April 1995|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002869
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Patricia Shepherd, MD||Edinburgh Cancer Centre at Western General Hospital|