BL22 Immunotoxin in Treating Patients With Refractory Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, or Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Antibodies; Immunoconjugates; Immunotoxins

Criteria

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