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 Blood, 15 September 2008, Vol. 112, No. 6, pp. 2272-2277.
Prepublished online as a Blood First Edition Paper on July 2, 2008; DOI 10.1182/blood-2008-01-131987.

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CLINICAL TRIALS AND OBSERVATIONS

Soluble CD22 as a tumor marker for hairy cell leukemia

Kakushi Matsushita1, Inger Margulies1, Masanori Onda1, Satoshi Nagata1, Maryalice Stetler-Stevenson2, and Robert J. Kreitman1

1 Laboratory of Molecular Biology and 2 Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD

CD22 is an important immunotherapeutic target on B-cell malignancies, particularly hairy cell leukemia (HCL), but its soluble extracellular domain, sCD22, has not yet been reported in the blood. By immunoaffinity and enzyme-linked immunosorbent assay techniques using anti-CD22 monoclonal antibodies, we identified the 100-kDa extracellular domain of CD22 and an 80-kDa processed form in serum of patients with HCL. The median sCD22 level measured by enzyme-linked immunosorbent assay was 18 ng/mL for 93 patients with HCL. sCD22 levels varied from 2.1 to 163 ng/mL and were higher (P < .001) than 23 normal donors (median, 0.6 ng/mL). More than 95% of normal donors had sCD22 levels less than 1.9 ng/mL. sCD22 levels were proportional to concentrations of circulating HCL cells (P = .002), and HCL spleen size (P < .001). sCD22 levels normalized with complete but not partial response to treatment. sCD22 levels up to 300 ng/mL had less than a 2-fold effect on the cytotoxicity of the anti-CD22 recombinant immunotoxin BL22. sCD22 levels may be useful to follow in patients with HCL and may be more specific than sCD25 in patients with CD22+/CD25– disease. Trials are listed on www.cancer.gov as NCT00002765 [ClinicalTrials.gov] , NCT00021983 [ClinicalTrials.gov] , NCT00074048 [ClinicalTrials.gov] , NCT00085085 [ClinicalTrials.gov] , NCT00337311 [ClinicalTrials.gov] , and NCT00462189 [ClinicalTrials.gov] .


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