Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049413
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2002-11-12
Brief Title:
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Pentostatin Cyclophosphamide And Rituximab PCR For B-Cell Chronic Lymphocytic Leukemia CLL And Small B-Cell Lymphocytic Lymphoma SLL Four Phase II Trials With Patient Stratification Based On Prior Therapy
Status:
COMPLETED
Status Verified Date:
2011-05
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 cancer cells from dividing so they stop growing or die Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining pentostatin and cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or lymphocytic lymphoma
PURPOSE Phase II trial to study the effectiveness of combining pentostatin and cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or lymphocytic lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of pentostatin cyclophosphamide and rituximab in terms of response rate time to treatment failure time to disease progression durability of response and overall survival in patients with B-cell chronic lymphocytic leukemia or small B-cell lymphocytic lymphoma
Determine the safety of this regimen in terms of acute subacute and chronic toxicity in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy no prior chemotherapy for chronic lymphocytic leukemia vs prior purine analog-based therapy fludarabine or cladribine but no alkylator therapy vs prior alkylator-based therapy chlorambucil or cyclophosphamide but no prior purine analog therapy vs prior therapy with alkylators and purine analogs but not as combination therapy
First course Patients receive rituximab IV over 1-4 hours on days 1-3 and pentostatin IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1
All subsequent courses Patients receive rituximab IV over 60 minutes pentostatin IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 160-240 patients 40-60 per stratum will be accrued for this study
Determine the efficacy of pentostatin cyclophosphamide and rituximab in terms of response rate time to treatment failure time to disease progression durability of response and overall survival in patients with B-cell chronic lymphocytic leukemia or small B-cell lymphocytic lymphoma
Determine the safety of this regimen in terms of acute subacute and chronic toxicity in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy no prior chemotherapy for chronic lymphocytic leukemia vs prior purine analog-based therapy fludarabine or cladribine but no alkylator therapy vs prior alkylator-based therapy chlorambucil or cyclophosphamide but no prior purine analog therapy vs prior therapy with alkylators and purine analogs but not as combination therapy
First course Patients receive rituximab IV over 1-4 hours on days 1-3 and pentostatin IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1
All subsequent courses Patients receive rituximab IV over 60 minutes pentostatin IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 160-240 patients 40-60 per stratum will be accrued for this study
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 |
|---|---|---|---|
| SUPEREN-CBRG-NIP-0201 | None | None | None |
| CBRG-NIP-0201 | None | None | None |
| NCI-V02-1712 | None | None | None |