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Prior treatments Tx included interferon (IFN), cladribine (CdA), pentostatin (DCF), rituximab (Ritux), anti-B4 blocked ricin (B4bR, and flu-darabine (Flud). Patients with prior splenectomy are indicated with either absent spleen or as having an accessory (Acc) spleen. The presence or absence (+ or —) of cytopenias is also listed to indicate whether patients had ANC <500/mm3, platelets <100,000/mm3, or Hb <11g/dL on enrollment. Patient 4 had splenectomy after cycle 3 due to an HCL-related bleeding disorder; the bleeding disorder responded but disease progressed in the peripheral blood prior to receiving the remaining 11 cycles of BL22. Dose-limiting toxicity included either vascular leak syndrome (VLS) or hemolytic uremic syndrome (HUS). Peak levels indicate the highest plasma level achieved with any of the doses of BL22 administered, as measured by cytotoxicity assay of plasma on Raji cells using pure BL22 for a standard curve. Neutralizing antibodies (Neut ABs) were + if the serum neutralized 1000 ng/mL of the cytotoxic activity of BL222 toward CD22+ Raji cells. Responses included partial response (PR) or complete remission (CR). The percent decrease in circulation HCL count (% Decr HCL) as a result of BL22 treatment is shown.

Prior treatments Tx included interferon (IFN), cladribine (CdA), pentostatin (DCF), rituximab (Ritux), anti-B4 blocked ricin (B4bR, and flu-darabine (Flud). Patients with prior splenectomy are indicated with either absent spleen or as having an accessory (Acc) spleen. The presence or absence (+ or —) of cytopenias is also listed to indicate whether patients had ANC <500/mm3, platelets <100,000/mm3, or Hb <11g/dL on enrollment. Patient 4 had splenectomy after cycle 3 due to an HCL-related bleeding disorder; the bleeding disorder responded but disease progressed in the peripheral blood prior to receiving the remaining 11 cycles of BL22. Dose-limiting toxicity included either vascular leak syndrome (VLS) or hemolytic uremic syndrome (HUS). Peak levels indicate the highest plasma level achieved with any of the doses of BL22 administered, as measured by cytotoxicity assay of plasma on Raji cells using pure BL22 for a standard curve. Neutralizing antibodies (Neut ABs) were + if the serum neutralized 1000 ng/mL of the cytotoxic activity of BL222 toward CD22+ Raji cells. Responses included partial response (PR) or complete remission (CR). The percent decrease in circulation HCL count (% Decr HCL) as a result of BL22 treatment is shown.

confirmed by renal biopsy. In each case, HUS presented with hematuria and hemoglobinuria by day 8 of cycle 2. These patients required 6-10 days of plasmapheresis, but not dialysis for complete resolution of renal function and correction of thrombocy-topenia and anemia. Both patients achieved a CR, patient 8 prior to HUS and patient 13 afterward, and in both cases all preexisting cytopenias resolved, as well as those related to HUS.

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