Clinical trial · Interventional
BL22 Immunotoxin in Treating Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antibody therapy | Procedure | — | UNRESOLVED |
| biological response modifier therapy | Procedure | — | UNRESOLVED |
| BL22 immunotoxin | Drug | — | UNRESOLVED |
| immunotoxin therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available