Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003248
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase II Study of Concurrent Fludarabine Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 Rituximab NSC 687451 Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
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 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 monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine given with or without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating patients who have untreated B-cell chronic lymphocytic leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine given with or without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating patients who have untreated B-cell chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the response rate and toxicity profile of concurrent and consolidative chimeric anti-CD20 monoclonal antibody IDEC-C2B8 rituximab therapy compared to consolidative rituximab therapy in patients with chronic lymphocytic leukemia treated with fludarabine II Assess the complete response CR rate in patients receiving concurrent therapy with rituximab and fludarabine III Assess the frequency of conversion of a partial response PR to a CR or stable disease to either PR or CR in patients receiving consolidative therapy with rituximab IV Follow the effects of rituximab and fludarabine on the immunologic markers CD4 CD8 IgG IgA and IgM V Assess the progression-free and overall survival of these patients
OUTLINE This is a randomized study Patients are stratified according to stage I and II vs III and IV Patients are assigned to 1 of 2 treatment arms Arm I consists of fludarabine and chimeric anti-CD20 monoclonal antibody IDEC-C2B8 rituximab induction and arm II consists of fludarabine induction Arm I Rituximab is administered IV over 4 hours on day 1 on day 3 and over 1 hour on day 5 of week 1 Subsequent doses are given over 1 hour on day 1 every 4 weeks for a total of 6 courses Fludarabine IV is administered over 10-30 minutes daily for 5 days during weeks 1 5 9 13 17 and 21 for a total of 6 courses Following the sixth course of fludarabine patients undergo clinical staging and are then observed for an additional 2 months after which they undergo repeat clinical staging including bone marrow aspiration Patients achieving a complete or partial response or stable disease then proceed to consolidation therapy consisting of weekly intravenous infusions of rituximab once weekly for 4 weeks Arm II Fludarabine Induction Patients receive fludarabine IV over 10-30 minutes daily for 5 days during weeks 1 5 9 13 17 and 21 for a total of 6 courses Patients then proceed as in arm I Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 100 patients will be accrued for this study within 12 months
OUTLINE This is a randomized study Patients are stratified according to stage I and II vs III and IV Patients are assigned to 1 of 2 treatment arms Arm I consists of fludarabine and chimeric anti-CD20 monoclonal antibody IDEC-C2B8 rituximab induction and arm II consists of fludarabine induction Arm I Rituximab is administered IV over 4 hours on day 1 on day 3 and over 1 hour on day 5 of week 1 Subsequent doses are given over 1 hour on day 1 every 4 weeks for a total of 6 courses Fludarabine IV is administered over 10-30 minutes daily for 5 days during weeks 1 5 9 13 17 and 21 for a total of 6 courses Following the sixth course of fludarabine patients undergo clinical staging and are then observed for an additional 2 months after which they undergo repeat clinical staging including bone marrow aspiration Patients achieving a complete or partial response or stable disease then proceed to consolidation therapy consisting of weekly intravenous infusions of rituximab once weekly for 4 weeks Arm II Fludarabine Induction Patients receive fludarabine IV over 10-30 minutes daily for 5 days during weeks 1 5 9 13 17 and 21 for a total of 6 courses Patients then proceed as in arm I Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 100 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| CDR0000066128 | REGISTRY | NCI Physicians Data Query | httpsreporternihgovquickSearchU01CA062475 |
| U10CA031946 | NIH | None | None |
| U01CA062475 | NIH | None | None |
| CLB-9712 | None | None | None |