Response To Bl22 In Patients With

A total of 87 cycles of BL22 were administered to 16 patients, each patient receiving 1-15 cycles (Table 33.3). A total of 11 out of 16 patients (68%) attained a CR, and 2 patients had a PR (12%). Patients 2 and 5 had marginal responses, with 98 and 99.5% reductions in circulating HCL counts, respectively, but less than 50% decreases in lymph node masses. A CR was attained in all three HCLv patients. Of 11 CRs, 6 (patients 6, 8, 9, 11, 12, and 16) had a CR after cycle 1, and patients 3, 4, 7, 10, and 13 had a CR after cycles 2, 9, 4, 3, and 2, respectively. Only one (patient 12) of the CRs had minimal residual disease in the bone marrow biopsy by immunohistochemistry at the time CR was documented. Complete clearing of circulating HCL cells was documented in 10 out of 11 CRs, and patient 7 had a decrease in HCL count from 32,000 to 1 cell/^L. Cytopenias resolved in all responders. Within the follow-up time of 4-22 (median 12) months, relapse was documented in three patients (patients 4, 7, and 12 after 8, 12, and 7 months, respectively), and all three of them were returned to CR with additional BL22. These relapses were asymptomatic in that they were detected by routine bone marrow biopsies, and the patients had not redeveloped cytopenias.

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