Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002869
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-96028 | None | None | None |
| MRC-LEUK-CML-V | None | None | None |