Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003639
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkins Lymphoma
Sponsor:
Scotland and Newcastle Lymphoma Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomised Controlled Trial of CID Chlorambucil Idarubicin Dexamethasone Versus CD Chlorambucil Dexamethasone for Induction of Remission in Low Grade Non-Hodgkins Lymphoma Kiel Classification Followed by Randomised Controlled Assessment of Standard Dose Interferon Versus Low Dose Interferon Versus No Further Therapy as Maintenance Treatment After Remission Induction
Status:
UNKNOWN
Status Verified Date:
2007-05
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of cancer cells and slow the growth of non-Hodgkins lymphoma It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Compare the remission induction rates and toxicity of chlorambucil plus dexamethasone with or without idarubicin in patients with stage II-IV low grade non-Hodgkins lymphoma II Assess the additional value of a period of consolidationmaintenance treatment utilizing low dose interferon alfa or standard dose interferon alfa versus no further treatment in relationship to the duration of event-free survival in these patients
OUTLINE This is a randomized open label controlled multicenter study Patients are randomized into one of two arms for induction chemotherapy Arm I Patients receive oral chlorambucil three times daily for 3 consecutive days oral idarubicin daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days Arm II Patients receive oral chlorambucil three times daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days Treatment for both arms continues for up to 6 courses in the absence of disease progression or unacceptable toxicity After 6 courses of chemotherapy patients are reassessed If they have achieved maximal complete response or good partial response patients are randomized into one of three arms Arm I Patients receive no further treatment until disease progresses Arm II Patients receive low dose interferon alfa subcutaneously three times per week for a maximum of 3 years in the absence of disease progression Arm III Patients receive standard dose interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of disease progression Patients are followed every 8-12 weeks for 3 years
PROJECTED ACCRUAL There will be 200 patients accrued into this study with approximately 150 patients entering the second phase of this study
OUTLINE This is a randomized open label controlled multicenter study Patients are randomized into one of two arms for induction chemotherapy Arm I Patients receive oral chlorambucil three times daily for 3 consecutive days oral idarubicin daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days Arm II Patients receive oral chlorambucil three times daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days Treatment for both arms continues for up to 6 courses in the absence of disease progression or unacceptable toxicity After 6 courses of chemotherapy patients are reassessed If they have achieved maximal complete response or good partial response patients are randomized into one of three arms Arm I Patients receive no further treatment until disease progresses Arm II Patients receive low dose interferon alfa subcutaneously three times per week for a maximum of 3 years in the absence of disease progression Arm III Patients receive standard dose interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of disease progression Patients are followed every 8-12 weeks for 3 years
PROJECTED ACCRUAL There will be 200 patients accrued into this study with approximately 150 patients entering the second phase of this 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-98034 | None | None | None |
| SNLG-NHL-VIII | None | None | None |