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About the Pivotal Trial of CLR 131 in Waldenstrom’s macroglobulinemia (WM) The pivotal trial is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. The study will enroll 50 WM patients. Patients in the trial will receive up to four doses of CLR 131 over two cycles (cycle one days 1, 15, and cycle two days 57, 71). The primary endpoint of the trial is response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival. An independent data monitoring committee (iDMC) will perform an interim safety and futility evaluation on the first 10 patients enrolled. The assessment will occur patient by patient and will conclude after the tenth patient is evaluated; there is no planned study stoppage. 

United statesLos angelesSikander ailawadhiAmerican society of clinical oncologyUniversity of southern californiaCellectar biosciences incInternational cancer centerDivision of hematology oncologyNorris cancer centerDivision of hematologyAmerican societyClinical oncologyTreatment free remissionOverall response rateRefractory waldenstromCancer biology