Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020943
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2001-07-11
Brief Title:
Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Peripheral 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 chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the two-year progression-free survival of patients with mantle cell lymphoma treated with intensive chemotherapy and rituximab with autologous peripheral blood stem cell PBSC transplantation
Determine the complete and partial response rates of patients treated with this regimen
Determine the disease-free and overall survival of patients treated with this regimen
Determine the autologous immune reconstitution in patients treated with this regimen
Determine the feasibility of this regimen in this patient population
Determine whether treatment with rituximab during autologous PBSC transplantation reduces the amount of contaminating lymphoma in the autologous PBSC product
OUTLINE This is a multicenter study
Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1 methotrexate IV over 4 hours on day 2 cyclophosphamide IV over 2 hours doxorubicin IV and vincristine IV on day 3 and oral prednisone on days 3-7 Patients also receive leucovorin calcium IV every 6 hours beginning on day 3 and continuing until blood levels of methotrexate are safe Filgrastim G-CSF is administered subcutaneously SC beginning on day 4 and continuing until blood counts recover
Induction therapy repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity Rituximab may be omitted during course 1 if circulating mantle cells are excessive Patients may receive a third course if more than 15 persistent bone marrow involvement is documented
Patients with stable or responding disease begin consolidation therapy 29 days after the start of the final course of induction therapy Patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 96 hours on days 1-4 Patients also receive rituximab IV over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing until leukapheresis is complete Patients undergo leukapheresis beginning between days 22-25 and continuing until adequate CD34 cells are collected
Beginning 4 weeks after recovery from consolidation therapy patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 Patients undergo autologous peripheral blood stem cell PBSC transplantation on day 0 Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover
After blood counts recover and more than 35 days after autologous PBSC transplantation patients receive rituximab IV over 4-6 hours weekly for 2 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for up to 10 years
PROJECTED ACCRUAL At least 45 patients will be accrued for this study within 2 years
Determine the two-year progression-free survival of patients with mantle cell lymphoma treated with intensive chemotherapy and rituximab with autologous peripheral blood stem cell PBSC transplantation
Determine the complete and partial response rates of patients treated with this regimen
Determine the disease-free and overall survival of patients treated with this regimen
Determine the autologous immune reconstitution in patients treated with this regimen
Determine the feasibility of this regimen in this patient population
Determine whether treatment with rituximab during autologous PBSC transplantation reduces the amount of contaminating lymphoma in the autologous PBSC product
OUTLINE This is a multicenter study
Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1 methotrexate IV over 4 hours on day 2 cyclophosphamide IV over 2 hours doxorubicin IV and vincristine IV on day 3 and oral prednisone on days 3-7 Patients also receive leucovorin calcium IV every 6 hours beginning on day 3 and continuing until blood levels of methotrexate are safe Filgrastim G-CSF is administered subcutaneously SC beginning on day 4 and continuing until blood counts recover
Induction therapy repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity Rituximab may be omitted during course 1 if circulating mantle cells are excessive Patients may receive a third course if more than 15 persistent bone marrow involvement is documented
Patients with stable or responding disease begin consolidation therapy 29 days after the start of the final course of induction therapy Patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 96 hours on days 1-4 Patients also receive rituximab IV over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing until leukapheresis is complete Patients undergo leukapheresis beginning between days 22-25 and continuing until adequate CD34 cells are collected
Beginning 4 weeks after recovery from consolidation therapy patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 Patients undergo autologous peripheral blood stem cell PBSC transplantation on day 0 Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover
After blood counts recover and more than 35 days after autologous PBSC transplantation patients receive rituximab IV over 4-6 hours weekly for 2 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for up to 10 years
PROJECTED ACCRUAL At least 45 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000068732 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-59909 | None | None | None |