BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: BL22 |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 36 |
| Study Start Date: | October 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
BL22 immunotoxin
|
Drug: BL22
Dosing via IV on Days 1,3, and 5.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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) |
More Information
Additional Information:
No publications provided by MedImmune LLC
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radhika Parikh, MedImmune Inc. |
| ClinicalTrials.gov Identifier: | NCT00074048 History of Changes |
| Obsolete Identifiers: | NCT00071318 |
| Other Study ID Numbers: | CDR0000341680, NCI-04-C-0014, NCI-6048 |
| Study First Received: | December 10, 2003 |
| Last Updated: | June 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MedImmune LLC:
|
refractory hairy cell leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Hairy Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Immunotoxins Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013