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BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BL22
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory hairy cell leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed hairy cell leukemia CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody Meets at least 1 of the following indications for treatment: Absolute neutrophil count less than 1,000/mm^3 Hemoglobin less than 10 g/dL Platelet count less than 100,000/mm^3 Absolute lymphocyte count greater than 20,000/mm^3 Symptomatic splenomegaly Meets 1 of the following response criteria: No response Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine CR or PR less than 4 years in duration after a second or later course of prior cladribine PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.2 mg/dL Albumin at least 3.0 g/dL Renal Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness that would preclude study participation Understand and give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy No prior BL22 immunotoxin More than 12 weeks since prior monoclonal antibody therapy Chemotherapy See Disease Characteristics More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day) Radiotherapy Not specified Surgery Not specified Other No other concurrent investigational agents

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

BL22 immunotoxin

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]

Full Information

First Posted
December 10, 2003
Last Updated
June 17, 2010
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00074048
Brief Title
BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
Official Title
Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia that has not responded to treatment with cladribine. PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin. Secondary Determine the response duration in patients treated with this drug. Determine the safety of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients. OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest. Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR. Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
refractory hairy cell leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
BL22 immunotoxin
Intervention Type
Drug
Intervention Name(s)
BL22
Intervention Description
Dosing via IV on Days 1,3, and 5.
Primary Outcome Measure Information:
Title
Response rate
Time Frame
After even cycle numbers (2,4,6,8,10)
Secondary Outcome Measure Information:
Title
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
Time Frame
30 days after last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hairy cell leukemia CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody Meets at least 1 of the following indications for treatment: Absolute neutrophil count less than 1,000/mm^3 Hemoglobin less than 10 g/dL Platelet count less than 100,000/mm^3 Absolute lymphocyte count greater than 20,000/mm^3 Symptomatic splenomegaly Meets 1 of the following response criteria: No response Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine CR or PR less than 4 years in duration after a second or later course of prior cladribine PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.2 mg/dL Albumin at least 3.0 g/dL Renal Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness that would preclude study participation Understand and give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy No prior BL22 immunotoxin More than 12 weeks since prior monoclonal antibody therapy Chemotherapy See Disease Characteristics More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day) Radiotherapy Not specified Surgery Not specified Other No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kreitman, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18596230
Citation
Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.
Results Reference
derived

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BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia

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