Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062296
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2003-06-05
Brief Title:
Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkins Lymphoma and CLL
Status:
COMPLETED
Status Verified Date:
2013-07
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 such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining epirubicin with rituximab may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the response rate time to progression and overall survival of patients with refractory or relapsed B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a non-randomized open-label multicenter study
Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 18-38 patients will be accrued for this study within 25-3 years
Determine the response rate time to progression and overall survival of patients with refractory or relapsed B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a non-randomized open-label multicenter study
Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 18-38 patients will be accrued for this study within 25-3 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 |
|---|---|---|---|
| CDR0000304711 | REGISTRY | PDQ Physician Data Query | None |