Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment
- Hairy cell leukemia (HCL) is highly responsive to but not curable by standard
chemotherapy, and also responds well to investigational agents called recombinant
immunotoxins which are being developed by the Laboratory of Molecular Biology (LMB).
- The investigators on this protocol are studying molecular and clinical aspects of HCL,
and how they compare to normal or to other disorders, including chronic lymphocytic
leukemia (CLL) non-Hodgkin's lymphoma (NHL), and acute lymphoblastic leukemia (ALL).
- Recombinant immunotoxins are fusion proteins containing a bacterial toxin connected to
a targeting ligand, like a single-chain antibody or a growth factor. Recombinant
immunotoxins currently under clinical development in the LMB include BL22 and a high
affinity variant, HA22, targeting CD22, LMB-2, targeting CD25, and SS1P, targeting
- LMB-2, BL22 and HA22 are being tested in purine analog resistant HCL.
- Other LMB trials include LMB-2 for cutaneous T-cell lymphoma, chronic lymphocytic
leukemia (CLL), and adult T-cell leukemia, and HA22 for non-Hodgkin's lymphoma and CLL.
- Primary: To allow the collection of a variety of clinical samples, including blood, urine,
lymphopheresis samples, and other tissues, in order to improve the efficacy and safety of
recombinant immunotoxins, to better understand the disease processes which are being
treated, and to determine eligibility and optimal timing for clinical testing. Specific
projects planned include 1) studying antibodies made against immunotoxins, 2) quantifying
tumor antigens by flow cytometry, 3) testing how well recombinant immunotoxins kill tumor
cells ex vivo, 4) quantifying soluble antigens like CD22 and CD25 in the serum of patients
and normal controls, 5) molecularly characterizing malignant B-cells by sequencing their
- Samples which are easily obtained, including blood and urine, may be obtained from
patients and normal volunteers.
- Samples requiring procedures, including bone marrow biopsy/aspiration, leukopheresis,
and any procedure done because of medical need, may be obtained from patients.
- Patients or normal donors are consented for the protocol and samples are obtained.
- This protocol does not involve treatment, although patients may also be on therapy or
Robert J Kreitman, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|