Protocol Number: 99-C-0014

Title:

Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

Number:

99-C-0014

Summary:

The purpose of the study is to evaluate the toxicity following administration of the recombinant immunotoxin BL22 in patients with CD22-positive malignancies (e.g., B-cell non-Hodgkin's lymphomas, chronic lymphocytic leukemia, prolymphocytic leukemia and hairy cell leukemia). The scientific basis for the proposed therapeutic study is that patients with these malignancies have cells which express high levels of the CD22 antigen on their cell surface. We propose to administer the immunotoxin BL22 to adult patients with CD22+ malignancies who fulfill the patient eligibility criteria. Patients will be followed closely for evidence of clinical or laboratory toxicity. Clinical response will be evaluated using routine hematologic and clinical evaluation and, when deemed appropriate by the Principal Investigator, by monitoring the phenotype of circulating B-cells or of biopsied tissues using antibodies to CD22. Serum concentrations of the administered immunotoxin and levels of anti-immunotoxin antibodies produced by the patients will also be monitored.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Prolymphocytic Leukemia (PLL)

Chronic Lymphocytic Leukemia (CLL)

Acute Lymphocytic Leukemia (ALL)

Hairy Cell Leukemia (HCL)

B-Cell Non-Hodgkin's Lymphoma (NHL)

Recruitment Keywords:

None

Conditions:

Chronic Lymphocytic Leukemia

Hairy Cell Leukemia

Non Hodgkin's Lymphoma

Prolymphocytic Leukemia

Investigational Drug(s):

BL22

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Entry of lethal doses of abrin, ricin and modeccin into the cytosol of HeLa cells

Active site of Pseudomonas aeruginosa exotoxin A Glutamic acid 553 is photolabeled by NAD and shows functional homology with glutamic acid 148 of diphtheria toxin

Reconstitution of diphtheria toxin from two nontoxic cross-reacting mutant proteins

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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