Status:
COMPLETED
BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
Lead Sponsor:
MedImmune LLC
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00074048
Start Date
October 1 2003
End Date
July 1 2008
Last Update
June 22 2010
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182