BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia|
- Response rate [ Time Frame: After even cycle numbers (2,4,6,8,10) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Dosing via IV on Days 1,3, and 5.
- Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin.
- 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.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Robert Kreitman, MD||National Cancer Institute (NCI)|