Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003924
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Interferon Alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkins Disease or Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A European Randomized Multicenter Study of Interferon Alfa-2b Versus No Treatment After Intensive Therapy and Autologous Hematopoietic Stem Cell Transplantation for Relapsing Lymphoma Patients Non-Hodgkin Lymphomas and Hodgkins Disease
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 Interferon-alfa may interfere with the growth of cancer cells Giving interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an effective treatment for Hodgkins disease or non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of interferon alfa-2b following chemotherapy and stem cell transplantation in treating patients who have recurrent or refractory Hodgkins disease or non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of interferon alfa-2b following chemotherapy and stem cell transplantation in treating patients who have recurrent or refractory Hodgkins disease or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the efficacy of interferon alfa-2b in reducing the relapse rate in patients with recurrent or refractory Hodgkins disease or non-Hodgkins lymphoma in second remission following high dose chemotherapy and autologous stem cell transplantation II Compare the time to disease progression and survival in this patient population treated with interferon alfa-2b vs no further treatment III Assess the tolerability of these treatment regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to lymphoma subtype Patients are randomized to one of two treatment arms Arm I Patients receive no further therapy following high dose chemotherapy and autologous stem cell transplantation Arm II Beginning 4 weeks after high dose chemotherapy and autologous stem cell transplantation patients receive interferon alfa-2b subcutaneously three times a week Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months until disease progression
PROJECTED ACCRUAL A total of 360 patients 180 per treatment arm will be accrued for this study within 4-5 years
OUTLINE This is a randomized multicenter study Patients are stratified according to lymphoma subtype Patients are randomized to one of two treatment arms Arm I Patients receive no further therapy following high dose chemotherapy and autologous stem cell transplantation Arm II Beginning 4 weeks after high dose chemotherapy and autologous stem cell transplantation patients receive interferon alfa-2b subcutaneously three times a week Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months until disease progression
PROJECTED ACCRUAL A total of 360 patients 180 per treatment arm will be accrued for this study within 4-5 years
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-99008 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067111 | REGISTRY | None | None |