Non Hodgkin Lymphoma Clinical Trial
BL22 Immunotoxin in Treating Patients With Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia
Summary
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Full Description
OBJECTIVES:
Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.
Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed chronic lymphocytic leukemia or prolymphocytic leukemia:
Failed prior standard chemotherapy and treatment is medically indicated as evidenced by 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 OR
Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma
Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated
No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies
No central nervous system disease requiring treatment
If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 60-100%
Life expectancy:
More than 6 months
Hematopoietic:
See Disease Characteristics
Hepatic:
ALT and AST less than 5 times upper limit of normal
Renal:
Adequate renal function
Pulmonary:
Adequate pulmonary function
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
At least 3 weeks since prior interferon for malignancy
Chemotherapy:
See Disease Characteristics
At least 3 weeks since prior cytotoxic chemotherapy for malignancy
Endocrine therapy:
Not specified
Radiotherapy:
At least 3 weeks since prior radiotherapy for malignancy
Surgery:
Not specified
Other:
At least 3 weeks since prior retinoids
At least 3 weeks since prior systemic therapy for cancer
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Bethesda Maryland, 20892, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.