Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080886
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2004-04-07
Brief Title:
Rituximab Carmustine Cytarabine Etoposide Melphalan Stem Cell Transplantation for Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Trial Of BEAMRituximabAutologous Hematopoietic Stem Cell Transplantation AHSCT For Patients With CD20 Positive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-10
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:
RATIONALE Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as carmustine cytarabine etoposide and melphalan work in different ways to stop cancer cells from dividing so they stop growing or die Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the levels of soluble CD20 antigen sCD20 in the blood before and after treatment with rituximab and carmustine cytarabine etoposide and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkins lymphoma
Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen
Determine the response rate in patients treated with this regimen
Determine the event-free survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
OUTLINE Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest
Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6 Patients also receive high-dose chemotherapy comprising carmustine IV on day -6 cytarabine IV and etoposide IV twice daily on days -5 to -2 and melphalan IV on day -1 Patients undergo autologous hematopoietic stem cell transplantation on day 0
Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks
Patients are followed at day 100 at 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Determine the levels of soluble CD20 antigen sCD20 in the blood before and after treatment with rituximab and carmustine cytarabine etoposide and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkins lymphoma
Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen
Determine the response rate in patients treated with this regimen
Determine the event-free survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
OUTLINE Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest
Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6 Patients also receive high-dose chemotherapy comprising carmustine IV on day -6 cytarabine IV and etoposide IV twice daily on days -5 to -2 and melphalan IV on day -1 Patients undergo autologous hematopoietic stem cell transplantation on day 0
Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks
Patients are followed at day 100 at 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000357306 | REGISTRY | PDQ Physician Data Query | None |