Status:
COMPLETED
BL22 Immunotoxin in Treating Patients With Refractory Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, or Non-Hodgkin's Lymphoma
Lead Sponsor:
MedImmune LLC
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating pat...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of recombinant BL22 immunotoxin in patients with CD22-positive refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or indolent ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell leukemia or lymphoma of 1 of the following types:
- Chronic lymphocytic leukemia
- Failed standard chemotherapy
- Prolymphocytic leukemia
- Failed standard chemotherapy
- Indolent non-Hodgkin's lymphoma, including mantle cell lymphoma
- Stage III or IV disease
- Failed ≥ 1 prior doxorubicin- or fludarabine-containing standard therapy
- CD22-positive disease, as evidenced by 1 of the following:
- More than 15% malignant cells react with anti-CD22 by immunohistochemistry
- More than 30% malignant cells are CD22-positive by fluorescence-activated cell sorting analysis
- More than 400 CD22 sites per malignant cell (average) by radiolabeled anti-CD22 binding
- Treatment is medically indicated, as evidenced by any of the following:
- Progressive disease-related symptoms
- Progressive cytopenias due to marrow involvement
- Progressive or painful splenomegaly or adenopathy
- Rapidly increasing lymphocytosis
- Autoimmune hemolytic anemia or thrombocytopenia
- Increased frequency of infections
- No neutralizing anti-toxin or anti-mouse immunoglobulin G (IgG) antibodies to BL22 or PE38
- No serum neutralization of \> 75% of the activity of 1 μg/mL of BL22
- No CNS disease requiring treatment
- No hairy cell leukemia
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- More than 6 months
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3\*
- Platelet count \> 40,000/mm\^3 NOTE: \*Patients with leukemia are eligible regardless of absolute neutrophil count; Grade III-IV pancytopenia or growth factor dependence allowed if due to disease
- Hepatic
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- ALT and AST \< 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 mg/dL
- Pulmonary
- FEV1 ≥ 60% of predicted
- DLCO ≥ 55% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior bone marrow transplantation allowed
- More than 3 weeks since prior biologic therapy, including interferon, denileukin diftitox, or LMB-2 immunotoxin
- More than 3 months since prior monoclonal antibody therapy (e.g., rituximab)
- Chemotherapy
- See Disease Characteristics
- More than 3 weeks since prior cytotoxic chemotherapy
- Endocrine therapy
- More than 1 week since prior steriods
- Less than 5 doses for non-treatment reasons (e.g., allergy prophylaxis)
- No evidence of disease response
- Radiotherapy
- More than 3 weeks since prior whole-body electron beam radiotherapy
- Radiotherapy within the past 3 weeks allowed provided the volume of bone marrow treated is \< 10% AND the patient has measurable disease located outside the radiation port
- Surgery
- Not specified
- Other
- More than 3 weeks since prior retinoids
- More than 3 weeks since other prior systemic therapy for this malignancy
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00126646
Start Date
June 1 2005
End Date
June 1 2009
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