NCT00002869

Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa
DRUG	cytarabine
DRUG	hydroxyurea

Timeline

• Start date: 1995-04-01
• First posted: 2004-02-16
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom