Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058396
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-04-07
Brief Title:
Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Of IDEC-152 Anti-CD23 Monoclonal Antibody In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2009-12
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 I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
Detailed Description:
OBJECTIVES
Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1 2 8 15 and 22
Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 2 of 6 or 3 of 10 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 15-50 patients will be accrued for this study within 6 months
Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1 2 8 15 and 22
Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 2 of 6 or 3 of 10 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 15-50 patients will be accrued for this study within 6 months
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 |
|---|---|---|---|
| CDR0000288828 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-02096 | None | None | None |