Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133991
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2005-08-22
Brief Title:
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitts Lymphoma or Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of Intensified CVP Rituximab and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-09
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving combination chemotherapy together with rituximab may kill more cancer cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitts lymphoma or leukemia
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitts lymphoma or leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate 1-year event-free survival and overall survival of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia treated with dose-intensified induction therapy comprising cyclophosphamide vincristine prednisone and rituximab followed by consolidation therapy comprising rituximab and high-dose cyclophosphamide
Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability of this regimen in these patients
Secondary
Determine the 3-year event-free survival and overall survival of patients treated with this regimen
Determine the general patterns of CNS and systemic relapse in patients treated with this regimen
OUTLINE This is a multicenter study
Dose-intensified CVP induction therapy Patients receive cyclophosphamide IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 and rituximab IV on days 1 and 8 and high-dose methotrexate IV with leucovorin calcium IV rescue on day 8 Patients receive filgrastim G-CSF subcutaneously SC once daily beginning on day 3 and continuing until blood counts recover Treatment repeats approximately every 14 days for 2 courses
CNS therapy Patients receive cytarabine intrathecally IT with or without hydrocortisone IT on days 1 4 and 11 of each induction therapy course Patients with evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly during any induction therapy treatment delay Patients who demonstrate CSF clearance receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses during consolidation therapy Patients with disease progression during induction therapy or persistent CNS involvement by lymphoma are removed from the study All other patients proceed to consolidation therapy
Consolidation therapy Patients receive rituximab IV on day -4 and high-dose cyclophosphamide IV on days -3 -2 -1 and 0 Patients receive G-CSF SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 Patients then receive rituximab IV once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
Primary
Determine the overall response rate 1-year event-free survival and overall survival of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia treated with dose-intensified induction therapy comprising cyclophosphamide vincristine prednisone and rituximab followed by consolidation therapy comprising rituximab and high-dose cyclophosphamide
Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability of this regimen in these patients
Secondary
Determine the 3-year event-free survival and overall survival of patients treated with this regimen
Determine the general patterns of CNS and systemic relapse in patients treated with this regimen
OUTLINE This is a multicenter study
Dose-intensified CVP induction therapy Patients receive cyclophosphamide IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 and rituximab IV on days 1 and 8 and high-dose methotrexate IV with leucovorin calcium IV rescue on day 8 Patients receive filgrastim G-CSF subcutaneously SC once daily beginning on day 3 and continuing until blood counts recover Treatment repeats approximately every 14 days for 2 courses
CNS therapy Patients receive cytarabine intrathecally IT with or without hydrocortisone IT on days 1 4 and 11 of each induction therapy course Patients with evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly during any induction therapy treatment delay Patients who demonstrate CSF clearance receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses during consolidation therapy Patients with disease progression during induction therapy or persistent CNS involvement by lymphoma are removed from the study All other patients proceed to consolidation therapy
Consolidation therapy Patients receive rituximab IV on day -4 and high-dose cyclophosphamide IV on days -3 -2 -1 and 0 Patients receive G-CSF SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 Patients then receive rituximab IV once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| NA_00035765 | OTHER | JHMIRB | httpsreporternihgovquickSearchP30CA006973 |
| P50CA096888 | NIH | None | None |
| P30CA006973 | NIH | None | None |