Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014560
Status:
TERMINATED
Last Update Posted:
2018-05-03
First Post:
2001-04-10
Brief Title:
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Phase I Trial Of Intravenous Bispecific Antibody 4G7XH22 In Patients With Refractory Or Relapsed Non-Hodgkins Lymphoma Or Chronic Lymphocytic Leukemia CLL
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Medarex supplier of BsAb stopped study due to toxicities experienced at other sites on unrelated trials halting manufacturing of BsAb
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE 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 antibody therapy in treating patients who have refractory or relapsed non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkins lymphoma or chronic lymphocytic leukemia
Assess the clinical toxicity of this antibody in these patients
OUTLINE This is a dose escalation study of bispecific antibody BsAb 4G7xH22
Patients receive sargramostim GM-CSF subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2 Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
Patients are followed weekly for 4 weeks monthly for 3 months and then periodically for 1 year
PROJECTED ACCRUAL Approximately 18 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkins lymphoma or chronic lymphocytic leukemia
Assess the clinical toxicity of this antibody in these patients
OUTLINE This is a dose escalation study of bispecific antibody BsAb 4G7xH22
Patients receive sargramostim GM-CSF subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2 Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
Patients are followed weekly for 4 weeks monthly for 3 months and then periodically for 1 year
PROJECTED ACCRUAL Approximately 18 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 |
|---|---|---|---|
| P30CA023108 | NIH | None | None |
| DMS-9806 | None | None | None |
| NCI-G01-1936 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |