A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.
The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).
Inclusion Criteria:
Exclusion Criteria:
Capital Federal, Buenos Aires C1426ANZ, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina
Derqui, Pilar, Buenos Aires B1629AHJ, Argentina
Goiania - GO, Goiás 74605-020, Brazil
Zrifin, 70300, Israel
Sittard-geleen, 6162 BG, Netherlands
St'Petersburg, 191024, Russia
St'Petersburg, 197341, Russia