Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024115
Status:
WITHDRAWN
Last Update Posted:
2015-04-28
First Post:
2001-09-13
Brief Title:
BL22 Immunotoxin in Treating Patients With Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia
Determine the pharmacokinetics including the terminal elimination serum half-life area under the curve and volume of distribution of recombinant BL22 immunotoxin in these patients
Determine the immunogenicity of recombinant BL22 immunotoxin in these patients
Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients
OUTLINE This is a dose-escalation study
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia
Determine the pharmacokinetics including the terminal elimination serum half-life area under the curve and volume of distribution of recombinant BL22 immunotoxin in these patients
Determine the immunogenicity of recombinant BL22 immunotoxin in these patients
Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients
OUTLINE This is a dose-escalation study
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 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-5336 | None | None | None |
| NCI-01-C-0213 | None | None | None |