Leukemia Clinical Trial
Official title:
Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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