Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
18 Years
N/A
Both
Leukemia
Trial Information
Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
After even cycle numbers (2,4,6,8,10)
Safety Issue:
No
Principal Investigator
Robert Kreitman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000341680
NCT ID:
NCT00074048
Start Date:
October 2003
Completion Date:
July 2008
Related Keywords:
- Leukemia
- refractory hairy cell leukemia
- Leukemia
- Leukemia, Hairy Cell
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
