Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126646
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2005-08-02
Brief Title:
BL22 Immunotoxin in Treating Patients With Refractory Chronic Lymphocytic Leukemia Prolymphocytic Leukemia or Non-Hodgkins Lymphoma
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
Phase I Study of BL22 A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22 Lymphomas
Status:
COMPLETED
Status Verified Date:
2010-06
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 BL22 immunotoxin can find tumor cells and kill them without harming normal cells
PURPOSE This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating patients with refractory B-cell chronic lymphocytic leukemia prolymphocytic leukemia or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating patients with refractory B-cell chronic lymphocytic leukemia prolymphocytic leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of recombinant BL22 immunotoxin in patients with CD22-positive refractory B-cell chronic lymphocytic leukemia prolymphocytic leukemia or indolent non-Hodgkins lymphoma
Determine the safety and efficacy of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the immunogenicity of this drug in these patients
Determine the effect of this drug on various components of the circulating cellular immune system in these patients
OUTLINE This is a nonrandomized dose-escalation study Patients are stratified according to disease type chronic lymphocytic leukemia vs non-Hodgkins lymphoma
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 27 days for up to 6 courses in the absence of neutralizing antibodies to BL22 or PE38 disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR Patients who relapse from a CR lasting 6 months may receive additional courses
Cohorts of 3-6 patients per stratum 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 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 24 patients 12 per stratum will be accrued for this study within 1-2 years
Determine the maximum tolerated dose of recombinant BL22 immunotoxin in patients with CD22-positive refractory B-cell chronic lymphocytic leukemia prolymphocytic leukemia or indolent non-Hodgkins lymphoma
Determine the safety and efficacy of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the immunogenicity of this drug in these patients
Determine the effect of this drug on various components of the circulating cellular immune system in these patients
OUTLINE This is a nonrandomized dose-escalation study Patients are stratified according to disease type chronic lymphocytic leukemia vs non-Hodgkins lymphoma
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 27 days for up to 6 courses in the absence of neutralizing antibodies to BL22 or PE38 disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR Patients who relapse from a CR lasting 6 months may receive additional courses
Cohorts of 3-6 patients per stratum 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 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 24 patients 12 per stratum will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-5336 | None | None | None |
| NCI-05-C-0171 | None | None | None |
| NCI-P6620 | None | None | None |