Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039130
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2002-06-06
Brief Title:
Rituximab Chemotherapy and Filgrastim in Treating Patients With Burkitts Lymphoma or Burkitts Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study Of Rituximab And Short Duration High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt LymphomaLeukemia
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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy Combining chemotherapy with rituximab and filgrastim may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitts lymphoma or Burkitts leukemia
PURPOSE Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitts lymphoma or Burkitts leukemia
Detailed Description:
OBJECTIVES
Determine the complete response rate in patients with previously untreated Burkitts lymphoma or Burkitts leukemia treated with rituximab and high-intensity chemotherapy with filgrastim G-CSF support
Determine the progression-free and overall survival of patients treated with this regimen
Determine the feasibility and toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease leukemia vs lymphoma
Course 1 Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7 Allopurinol PO will be given on days 1-14
Courses 2 4 and 6 Patients receive ifosfamide IV over 1 hour daily on days 1-5 vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1 leucovorin calcium IV over 15 minutes every 6 hours on day 2 cytarabine IV over 2 hours on days 4 and 5 and etoposide IV over 1 hour daily on days 4 and 5 oral dexamethasone daily on days 1-5 and methotrexate and cytarabine intrathecally IT on day 1 During course 2 patients receive rituximab IV over 1-4 hours on days 8 10 and 12 During courses 4 and 6 patients receive rituximab IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 7 and continuing until blood counts recover
Courses 3 5 and 7 Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1 leucovorin calcium IV every 6 hours on day 2 doxorubicin IV daily on days 4 and 5 oral dexamethasone daily on days 1-5 methotrexate and cytarabine IT on day 1 and rituximab IV over 1 hour on day 8 Patients also receive G-CSF as in courses 2 4 and 6 After course 3 treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 100 patients 50 per stratum will be accrued for this study within 3 years
Determine the complete response rate in patients with previously untreated Burkitts lymphoma or Burkitts leukemia treated with rituximab and high-intensity chemotherapy with filgrastim G-CSF support
Determine the progression-free and overall survival of patients treated with this regimen
Determine the feasibility and toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease leukemia vs lymphoma
Course 1 Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7 Allopurinol PO will be given on days 1-14
Courses 2 4 and 6 Patients receive ifosfamide IV over 1 hour daily on days 1-5 vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1 leucovorin calcium IV over 15 minutes every 6 hours on day 2 cytarabine IV over 2 hours on days 4 and 5 and etoposide IV over 1 hour daily on days 4 and 5 oral dexamethasone daily on days 1-5 and methotrexate and cytarabine intrathecally IT on day 1 During course 2 patients receive rituximab IV over 1-4 hours on days 8 10 and 12 During courses 4 and 6 patients receive rituximab IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 7 and continuing until blood counts recover
Courses 3 5 and 7 Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1 leucovorin calcium IV every 6 hours on day 2 doxorubicin IV daily on days 4 and 5 oral dexamethasone daily on days 1-5 methotrexate and cytarabine IT on day 1 and rituximab IV over 1 hour on day 8 Patients also receive G-CSF as in courses 2 4 and 6 After course 3 treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 100 patients 50 per stratum 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 |
|---|---|---|---|
| CDR0000069354 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-10002 | None | None | None |