Phase II Trial of BL22 Immunotoxin in Hairy Cell Leukemia
Protocol # 04-C-0014
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Patients with hairy cell leukemia, when resistant to standard chemotherapy such as cladribine, need additional options. Despite cladribine resistance, the malignant cells still display the marker CD22, which makes them potential targets for the recombinant immunotoxin BL22.
Who is eligible for this trial? (PDQ)
- Histologically confirmed hairy cell leukemia
- CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody
- Meets at least 1 of the following indications for treatment:
- Absolute neutrophil count less than 1,000/mm3
- Hemoglobin less than 10g/dl
- Platelet count less than 100,000/mm3
- Absolute lymphocyte count greater than 20,000/mm3
- Symptomatic splenomegaly
- Meets one of the following response criteria:
- No response
- No complete response (CR) or partial remission (PR) less than 2 years in duration after the last course of prior cladribine
- CR or PR less than 4 years in duration after a second or later course of prior cladribine
What types of drugs or therapies are being used?
Recombinant immunotoxin BL22, a protein composed of a binding antibody part, and a toxin. After binding to and being internalized by target cells, the toxin kills the cell with extreme potency. BL22 therefore kills hairy cell leukemia cells directly without needing help from the immune system, which is often damaged due to disease and prior treatment.
What is the treatment plan? (PDQ)
- Dose-escalation study
- Patients are stratified according to remission duration after the last course of prior cladribine
- Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest
- Patients are then evaluated at 8 weeks; patients achieving complete hematologic remission are followed; all other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5
- Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of disease progression or unacceptable toxicity
- Patients achieving complete remission (CR) without minimal residual disease (MRD) receive 2 courses beyond CR; patients achieving CR with MRD receive 4 courses beyond CR
- Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter
What is the frequency and duration of the visits?
Blood samples are sent ahead of time and tested free of charge at NIH to determine eligibility. During the first visit, patients typically spend 3 days taking baseline tests. When treatment begins, a cycle includes treatment by 30-minute infusion every other day for 3 doses, and patients usually return home a week after beginning. Patients who have not made antibodies against BL22 and whose disease has not worsened on treatment may be eligible for additional cycles at approximate monthly intervals. Some patients only need 1 cycle if assessment 8 weeks after the first cycles shows a remission. BL22 may be given as an inpatient or outpatient.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Robert J. Kreitman received his M.D. from Ohio State University in 1985 and obtained his internal medicine residency training at Duke University from 1985 to 1988. He received his medical oncology fellowship training at the NIH from 1988 to 1991, has been working in the immunotoxin field since 1989, and has been directing clinical trials with immunotoxins since 1996. He won Federal Technology Transfer awards in 1994 and 1999-2005. He has won several awards from the U.S. Public Health Service, including the Commendation Medal 1999 and the Outstanding Service Medal in 2002.
Where is this trial taking place?
Warren Grant Magnuson Clinical Center
National Institutes of Health
NCI Laboratory of Molecular Biology
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Robert J. Kreitman, M.D.
Principal Investigator
Phone: 301-496-6947
kreitmar@mail.nih.gov
Referrals:
Linda Ellison, R.N.
Research Nurse
Phone: 301-496-9458
Fax: 240-220-7677
ellisonl@mail.nih.gov
Rita Mincemoyer, R.N.
Research Nurse
Phone: 301-594-1778
Fax: 240-220-7677
mincemor@mail.nih.gov
Elizabeth Maestri, R.N.
Research Nurse
Phone: 301-402-5633
Fax: 240-220-7677
maestrie@mail.nih.gov
Where can additional information be found?
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