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Fractionated Radioimmunotherapy With (90)Y-epratuzumab in,Non-Hodgkin's Lymphoma Appears Safe and Active in a Phase I/II,Study

Both the objective and complete response rates appear to increase with higher cumulative doses. Objective responses occurred for 41% of patients at the lowest total doses of 5-10 mCi/m(2), compared to 55% in the groups receiving 15-20 mCi/m(2), 63% in the 22.5-37.5 mCi/m(2) cohorts, and 90% receiving the highest cumulative doses of 37.5-45 mCi/m(2). Similarly, complete responses occurred for 29% of patients in the 5-10 mCi/m(2) total dose groups, compared to 45% at 15-20 mCi/m(2), 44% at 22.5-37.5 mCi/m(2), and 60% at 37.5-45 mCi/m(2).

Importantly, 64% of patients who had received prior rituximab-containing regimens responded to (90)Y-epratuzumab, as well as 41% of patients with prior bone marrow transplant. Moreover, responses were seen in patients with different types of NHL. Sixty-eight percent of patients with follicular lymphoma responded to the RAIT, compared to 57% for mantle cell lymphoma, 22% for diffuse large B-cell lymphoma, and all 3 patients with marginal zone lymphoma.

"We are very encouraged by these results. Not only did we observe high response rates but, more importantly, the responses were seen in patients with different types of NHL, and in rituximab-treated or naïve patients with or without a history of bone marrow transplants," remarked Dr. Franck Morschhauser.

Adult patients with documented B-cell NHL who failed at least one prior regimen of standard chemotherapy were eligible for this study. At the time of reporting, 58 patients with a median of 3 prior therapies have completed treatment. Patients were treated once weekly for two or three consecutive weeks and the (90)Y dose was escalated in successive patient cohorts. For patients with prior bone marrow transplants, dose escalation stopped at 10 mCi/m(2) total dose (5.0 mCi/m(2) x 2 weeks). For patients without prior bone marrow transplants, however, the study is continuing at the highest tested level of 45 mCi/m(2) total dose (15.0 mCi/m(2) x 3 weeks).


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