Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007852
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2001-01-06
Brief Title:
Rituximab Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-08
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkins lymphoma treated with rituximab and high-dose carmustine etoposide cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation II Determine the toxicity profile of this regimen in these patients III Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population
OUTLINE Patients receive two doses of rituximab IV over 3-4 hours 1 week apart Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab Following stem cell collection patients receive a third dose of rituximab IV as above between days -10 and -6 Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6 etoposide IV twice daily and cytarabine IV on days -5 to -2 and melphalan IV on day -1 On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation After transplantation patients receive a fourth dose of rituximab as above at approximately day 30 and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 23-40 patients will be accrued for this study within 3 years
OUTLINE Patients receive two doses of rituximab IV over 3-4 hours 1 week apart Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab Following stem cell collection patients receive a third dose of rituximab IV as above between days -10 and -6 Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6 etoposide IV twice daily and cytarabine IV on days -5 to -2 and melphalan IV on day -1 On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation After transplantation patients receive a fourth dose of rituximab as above at approximately day 30 and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 23-40 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| NCI-V00-1634 | OTHER_GRANT | National Cancer Institute | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |