Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003757
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Rituximab IDEC-C2B8 Mabthera in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine CDA
Status:
COMPLETED
Status Verified Date:
2012-05
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy
Detailed Description:
OBJECTIVES
Determine the rate of complete and partial remission remission duration and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine
Determine the acute and long term toxicity of rituximab in these patients
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV over several hours once a week for 4 weeks
Patients are followed every 3 months for 3 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 8-25 patients will be accrued for this study within 3 years
Determine the rate of complete and partial remission remission duration and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine
Determine the acute and long term toxicity of rituximab in these patients
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV over several hours once a week for 4 weeks
Patients are followed every 3 months for 3 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 8-25 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 |
|---|---|---|---|
| EU-98073 | None | None | None |
| SWS-SAKK-3198 | None | None | None |