BL22 Immunotoxin in Treating Patients With Non-Hodgkin's... | NCT00024115 | Trialant
NCT00024115
Sponsor
National Cancer Institute (NCI)
Status
Withdrawn
Last Update Posted
Apr 28, 2015Estimated
Enrollment
0Actual
Phase
Phase 1
Conditions
Leukemia
Lymphoma
Interventions
BL22 immunotoxin
antibody therapy
biological response modifier therapy
immunotoxin therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00024115
Obsolete or Duplicate NCT IDs
NCT00021593
Organization Study
CDR0000068892
Secondary IDs
ID
Type
Description
Link
NCI-01-C-0213
NCI-5336
Brief Title
BL22 Immunotoxin in Treating Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official Title
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Dec 2006
Overall Recruitment Status or Expanded Access Status
Withdrawn
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Not provided
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Sep 13, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 27, 2015
Last Update Posted Date
Apr 28, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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-Hodgkin's 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-Hodgkin's 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.
Conditions Module
Conditions
Leukemia
Lymphoma
Keywords
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
stage III grade I follicular small cleaved cell lymphoma
stage III grade II follicular mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV grade I follicular small cleaved cell lymphoma
stage IV grade II follicular mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
0Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BL22 immunotoxin
Drug
antibody therapy
Procedure
biological response modifier therapy
Procedure
immunotoxin therapy
Procedure
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed chronic lymphocytic leukemia or prolymphocytic leukemia:
Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following: