Protocol Number: 04-C-0014

Title:

Phase II Trial of BL22 Immunotoxin in Hairy Cell Leukemia

Number:

04-C-0014

Summary:

This study will examine the safety and effectiveness of the experimental drug BL22 for treating hairy cell leukemia. BL22 can kill leukemia cells that have a protein on their surface called CD22. The drug is made up of two parts - a protein that binds to the CD22 protein on a cancer cell and a toxin (type of poison) that kills the cancer cell to which it binds. In a preliminary study of BL22 in patients with leukemias and lymphomas, several patients with hairy cell leukemia have achieved disease remission ranging from 6 to 43 months.

Patients 18 years of age and older with hairy cell leukemia whose cancer cells have the CD22 protein may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, electrocardiogram (EKG), chest x-ray, and bone marrow biopsy.

Participants will undergo the following tests and procedures:

- BL22 treatment: BL22 is given by intravenous (through a vein) infusion over 30 minutes on days 1, 3, and 5 of each 4-week treatment cycle. The drug is infused through a central venous catheter (plastic tube placed in a large vein). The first infusion is given on an inpatient basis, with subsequent cycles given as outpatients. Acetaminophen, ranitidine, and hydroxyzine are given around the time of the BL22 infusion to reduce the risk of an allergic reaction to the drug. Other treatments, such as transfusions and antibiotics, are given if required. Patients are evaluated 8 weeks after the first cycle. Those whose blood counts improve to a certain level are observed without further treatment. Others may receive up to 9 nine additional cycles of BL22 every 4 weeks unless the disease worsens, serious side effects develop, or the patient decides to withdraw from the study.

- Blood tests: A small amount of blood is drawn before, during, and after each treatment cycle to measure the amount of BL22 in the blood, the effects of the drug on cancer cells in the blood, and to monitor for drug side effects. Blood tests are also done before and during each cycle to assess the immune system response to BL22.

- Disease progress is evaluated before each cycle and at follow-up visits. These evaluations include a physical examination, blood tests, chest x-ray, and electrocardiogram (EKG). Bone marrow biopsy, computed tomography (CT) scan, and echocardiogram (heart ultrasound test) are done before starting the first treatment cycle and after every two cycles, or more often if they contribute to an understanding of how the leukemia is reacting to BL22.

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): 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

Keyword(s):

BL22

HCL

Immunotoxin

Oncology

Hairy Cell Leukemia

Recruitment Keyword(s):

None

Condition(s):

Leukemia, Hairy Cell

Investigational Drug(s):

BL22 {RFB4(dsFv)-PE38}

Investigational Device(s):

None

Interventions:

Drug: BL22 {RFB4(dsFv)-PE38}

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):

Frassoldati A, Lamparelli T, Federico M, Annino L, Capnist G, Pagnucco G, Dini E, Resegotti L, Damasio EE, Silingardi V. Hairy cell leukemia: a clinical review based on 725 cases of the Italian Cooperative Group (ICGHCL). Italian Cooperative Group for Hairy Cell Leukemia. Leuk Lymphoma. 1994 Apr;13(3-4):307-16. Review.

BOURONCLE BA, WISEMAN BK, DOAN CA. Leukemic reticuloendotheliosis. Blood. 1958 Jul;13(7):609-30. No abstract available.

Vardiman JW, Golomb HM. Autopsy findings in hairy cell leukemia. Semin Oncol. 1984 Dec;11(4):370-80.

• 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.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009