Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001430
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
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:
This is a randomized study of combination chemotherapy EPOCH II versus EPOCH II and immunotherapy with peripheral blood stem cells PBSC and IL-2 in patients with relapsed Hodgkins and non-Hodgkins lymphomas and untreated patients with low-grade non-Hodgkins lymphomas The chemotherapy entails the administration of multiple cycles of infusional doxorubicin etoposide and vincristine chemotherapy total of 3 alternating with cycles of high-dose cyclophosphamide 3 cycles Patients will be randomized on a 21 basis to either receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2 following the last cycle of chemotherapy In all patients immunological monitoring for NKLAK activity T cell number and function will be performed The therapy is specifically targeted for patients who would be candidates for high-dose chemotherapy with stem cell support
Detailed Description:
This is a randomized study of combination chemotherapy EPOCH II versus EPOCH II and immunotherapy with peripheral blood stem cells PBSC and IL-2 in patients with relapsed Hodgkins and non-Hodgkins lymphomas and untreated patients with low-grade non-Hodgkins lymphomas The chemotherapy entails the administration of multiple cycles of infusional doxorubicin etoposide and vincristine chemotherapy total of 3 alternating with cycles of high-dose cyclophosphamide 3 cycles Patients will be randomized on a 21 basis to either receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2 following the last cycle of chemotherapy In all patients immunological monitoring for NKLAK activity T cell number and function will be performed The therapy is specifically targeted for patients who would be candidates for high-dose chemotherapy with stem cell support
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 |
|---|---|---|---|
| 95-C-0073 | None | None | None |