Clinical trial · Interventional
BL22 Immunotoxin in Treating Patients With Refractory Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, or Non-Hodgkin's Lymphoma
Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
NCT00126646CI-TRIAL-00003580completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: 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 patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antibody-drug conjugate 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:
* 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 malignancyReferences
Publications (1)
- RESULTKreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1. PMID 16061911