Researchers who are studying hairy cell leukemia, and how the disease compares with other
disorders, are interested in obtaining additional samples from leukemia patients and healthy
volunteers. The investigators are particularly interested in samples from individuals who
have diseases that can be treated with a new type of drug called immunotoxin, in which an
antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell.
To collect a variety of clinical samples, including blood, urine, lymph samples, and other
tissues, in order to study the samples and develop new treatments for leukemia.
Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds
of blood and lymphatic system cancers, or who are healthy volunteers.
Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and
tumor tissue samples as requested by the researchers. Healthy volunteers will provide
only blood and urine samples.
No treatment will be given as part of this protocol.
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.
To allow the collection of a variety of clinical samples, including blood, urine,
lymphopheresis samples, and other tissues, to better understand the disease processes which
are being studied, or to determine eligibility and/or optimal timing for clinical testing.
Specific projects planned may include:
studying antibodies made against immunotoxins
quantifying tumor antigens by flow cytometry and other methods
testing how well recombinant immunotoxins and other agents kill tumor cells ex vivo
molecularly characterizing malignant B-cells by sequencing their immunoglobulin
rearrangements and other genes.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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