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news.Cell Therapeutics has reported positive results of a Phase II clinical study, which demonstrated that the addition of radioimmunotherapy to chemotherapy for previously untreated patients with non-follicular indolent non-Hodgkin's lymphoma was both well tolerated and effective, producing a 100% complete remission at end of treatment with an estimated 89% of patients remaining in remission at three years.
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The study, conducted at the Institute of Hematology and Medical Oncology at University of Bologna, Italy, investigated the use of a single dose of Zevalin (Ibritumomab Tiuxetan) as consolidation therapy following treatment with a regimen of fludarabine and mitoxantrone (FM chemotherapy) among 26 patients with newly diagnosed non-follicular indolent non-Hodgkin’s lymphoma (NHL). FM chemotherapy resulted in 50% of patients achieving a complete remission (CR) and 30% achieving a partial remission (PR). Of the 20 patients (13 with CR and 7 with PR) who were evaluable for Zevalin consolidation, 100% obtained a CR at the end of treatment. With a median follow up of 20 months, the estimated three-year progression free survival (PFS) was 89.5%.
Jack Singer, chief medical officer of CTI, said: “This single arm, non-randomized Phase II trial provides additional insights into the potential utility of RIT in intermediate grade NHL, a subtype where CRs are infrequent with rituximab therapy.”