Protocol Number: 05-C-0171

Title:

Phase I Study of BL22, a Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas

Number:

05-C-0171

Summary:

This Phase I study will determine how much of the experimental drug BL22 can safely be given to patients with certain leukemias and lymphomas and how long the drug lasts in the bloodstream. BL22 consists of two parts-an antibody that binds to a protein on the cancer cells called CD22 and a toxin that kills the cells. The antibody carries the toxin to the cancer sites and selectively kills the tumor cells. To determine the highest safe dose of BL22, small groups of patients receive the drug in increasingly higher doses, until the maximum tolerated dose is reached.

Patients 18 years of age and older with non-hairy cell leukemia or lymphoma may be eligible for this study. Their cancer cells must have the CD22 protein receptor. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, bone marrow biopsy, and chest x-ray and imaging studies to evaluate the extent of disease.

Participants undergo the following tests and procedures:

-Drug therapy: Patients are admitted to the NIH Clinical Center for BL22 infusions through a vein (intravenous, or i.v.) at the beginning of each treatment cycle. A cycle consists of 3 doses of drug, given on days 1, 3 and 5, followed by at least 4 weeks off drug. To prevent kidney damage, patients receive i.v. fluid before and after each dose, each time over 2-4 hours. They also receive a slower infusion of about 2 pints per day during the first week of the treatment cycle. Patients who do well can be discharged from the hospital on day 8.

-Blood tests: Blood is drawn frequently; up to a pint of blood may be collected every 6 weeks. For example, around the time of dosing on days 1, 3 and 5, about a teaspoon of blood is drawn 19 times to determine, in part, how BL22 is distributed in the body. On day 11 and again about a week later, patients have blood tests to monitor the effects of BL22 on the body's normal functions. Patients are monitored for anemia and given transfusions, if required.

-CT scan: A CT scan and other tests are done about a month after beginning BL22 to determine the possible benefits and toxicity of the drug.

Depending on their response to treatment, patients may be eligible for up to five additional cycles of BL22. Patients who develop severe toxicity to the drug, or whose immune system rejects the drug, or whose disease worsens with treatment may be taken off the study.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

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

Keyword(s):

Biologic Therapy

Monoclonal Antibody

Immunotherapy

Pseudomonas Exotoxin

Targeted Therapy

Recruitment Keyword(s):

Chronic Lymphocytic Leukemia

CLL

Lymphoma

B-cell Non-Hodgkin's Lymphoma

Condition(s):

Leukemia, Lymphocytic, Chronic

Lymphoma, Non-Hodgkin

Leukemia, Prolymphocytic

Investigational Drug(s):

BL-22

Investigational Device(s):

None

Interventions:

Drug: BL-22

Supporting Site:

National Cancer Institute

Contact(s):

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.

Citation(s):

Eiklid K, Olsnes S, Pihl A. Entry of lethal doses of abrin, ricin and modeccin into the cytosol of HeLa cells. Exp Cell Res. 1980 Apr;126(2):321-6. No abstract available.

Carroll SF, Collier RJ. 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. J Biol Chem. 1987 Jun 25;262(18):8707-11.

Uchida T, Pappenheimer AM Jr, Harper AA. Reconstitution of diphtheria toxin from two nontoxic cross-reacting mutant proteins. Science. 1972 Feb 25;175(24):901-3. No abstract available.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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