Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026351
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-11-09
Brief Title:
Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Pharmatech Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkins Lymphoma NHL Including Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2002-07
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 such as rituximab 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 rituximab in treating patients who have non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in patients with low-grade B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab
Determine the duration of response median time to progression and survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV alone on day 1 of course 1 only Patients then receive rituximab IV and pentostatin IV on days 8 15 and 22 An additional course with both drugs is administered on days 36 43 and 50 Patients with progressive disease or a complete response receive no further treatment Patients with responsive disease but less than a complete response receive one additional course of therapy as above
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 50 non-Hodgkins lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study
Determine the response rate in patients with low-grade B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab
Determine the duration of response median time to progression and survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV alone on day 1 of course 1 only Patients then receive rituximab IV and pentostatin IV on days 8 15 and 22 An additional course with both drugs is administered on days 36 43 and 50 Patients with progressive disease or a complete response receive no further treatment Patients with responsive disease but less than a complete response receive one additional course of therapy as above
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 50 non-Hodgkins lymphoma and 50 chronic lymphocytic leukemia patients 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 |
|---|---|---|---|
| SUPERGEN-PHARMATECH-N007 | None | None | None |
| PHARMATECH-N007 | None | None | None |
| PHARMATECH-20001631 | None | None | None |