Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003658
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Pentostatin Cyclophosphamide and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-06
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 tumor cells and either kill them or deliver tumor-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 cyclophosphamide and rituximab in treating patients who have chronic lymphocytic leukemia or other B-cell cancers that have been treated previously
PURPOSE Phase II trial to study the effectiveness of combining pentostatin cyclophosphamide and rituximab in treating patients who have chronic lymphocytic leukemia or other B-cell cancers that have been treated previously
Detailed Description:
OBJECTIVES
Determine the dose of cyclophosphamide with filgrastim G-CSF support that can be safely administered with pentostatin and rituximab in patients with previously treated intermediate- or high-risk chronic lymphocytic leukemia or other low-grade B-cell malignancies Phase I closed to accrual effective 11272001
Characterize the toxicity of this regimen in these patients
Determine the incidence of response in these patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of cyclophosphamide CTX
Phase I Patients receive CTX IV followed by pentostatin IV on day 1 of course 1 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 3 and continuing until blood counts recover During the second and subsequent courses patients receive CTX IV pentostatin IV and rituximab IV on day 1 Patients also receive G-CSF as in course 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients with at least a partial response after the third course receive an additional 3 courses
Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Phase I closed to accrual effective 11272001
Phase II Patients receive CTX at the recommended phase II dose and treatment as above
Patients are followed at least every 3 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for the phase I portion of this study Phase I closed to accrual effective 11272001 A total of 14-30 patients will be accrued for the phase II portion of this study within 25 years
Determine the dose of cyclophosphamide with filgrastim G-CSF support that can be safely administered with pentostatin and rituximab in patients with previously treated intermediate- or high-risk chronic lymphocytic leukemia or other low-grade B-cell malignancies Phase I closed to accrual effective 11272001
Characterize the toxicity of this regimen in these patients
Determine the incidence of response in these patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of cyclophosphamide CTX
Phase I Patients receive CTX IV followed by pentostatin IV on day 1 of course 1 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 3 and continuing until blood counts recover During the second and subsequent courses patients receive CTX IV pentostatin IV and rituximab IV on day 1 Patients also receive G-CSF as in course 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients with at least a partial response after the third course receive an additional 3 courses
Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Phase I closed to accrual effective 11272001
Phase II Patients receive CTX at the recommended phase II dose and treatment as above
Patients are followed at least every 3 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for the phase I portion of this study Phase I closed to accrual effective 11272001 A total of 14-30 patients will be accrued for the phase II portion of this study within 25 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1482 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066751 | REGISTRY | None | None |