Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021983
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-08-10
Brief Title:
Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BL22 a Recombinant Immunotoxin for Treatment of CD22 Leukemias and Lymphomas
Status:
COMPLETED
Status Verified Date:
2006-01
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 An immunotoxin can locate cancer cells and kill them without harming normal cells This may be an effective treatment for hairy cell leukemia
PURPOSE Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia
PURPOSE Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia
Detailed Description:
OBJECTIVES
Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22 hairy cell leukemia
Define the pharmacokinetics of this drug including the terminal elimination serum half-life area under the curve and volume of distribution in these patients
Evaluate 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 dose-escalation study
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats at least every 42 days for up to 4 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 at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 46 patients will be accrued for this study within 3 years
Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22 hairy cell leukemia
Define the pharmacokinetics of this drug including the terminal elimination serum half-life area under the curve and volume of distribution in these patients
Evaluate 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 dose-escalation study
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats at least every 42 days for up to 4 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 at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 46 patients will be accrued for this study within 3 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-T98-0063 | None | None | None |
| NCI-99-C-0014 | None | None | None |