Tadeusz Robak1, Jerzy Błoński1, Aleksander Bartłomiej Skotnicki2, Magdalena Piotrowska2, Tomasz Wróbel3, Justyna Rybka3, Janusz Kłoczko4, Łukasz Bołkun4, Bożena Katarzyna Budziszewska5, Urszula Walczak5, Anatoly Uss6, Marta Fidecka7, Piotr Smolewski8. 1. Department of Hematology, Copernicus Memorial Hospital, Medical University of Lodz, Lodz, Poland. 2. Department of Hematology, Jagiellonian University, Kraków, Poland. 3. Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland. 4. Department of Hematology, Medical University of Białystok, Białystok, Poland. 5. Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. 6. City Clinical Hospital No. 9, Minsk, Belarus. 7. Roche Poland, Warsaw, Poland. 8. Department of Experimental Hematology, Copernicus Memorial Hospital, Medical University of Lodz, Lodz, Poland.
Abstract
OBJECTIVES: PALG CLL4 is the first, randomized, phase IIIb study with rituximab, cladribine, and cyclophosphamide (RCC) induction and subsequent maintenance with rituximab in previously untreated chronic lymphocytic leukemia (CLL) patients. METHODS: The induction treatment consisted of 6 RCC cycles regimen. Patients with complete response (CR) or partial response (PR) after an induction phase were randomized into a maintenance arm with rituximab or an observational arm. RESULTS: In the intention-to-treat population, 97 patients completed the induction phase with an overall response rate (ORR) of 73.2% (CR 22.7%, PR 50.5%). Subsequently, 66 patients were randomized into the rituximab maintenance arm (n = 33) or the observational arm (n = 33). CR rates were 57.1% in the maintenance group vs 50% in the observational group. PFS was significantly longer in the rituximab maintenance vs the observational arm (P = .028). The multivariate Cox model indicated that del17p (P = .006) and elevated beta-2-microglobulin (P = .015) significantly increased the hazard ratio (HR) of progression, whereas the presence of CD38 (P = .013) significantly decreased it; maintenance therapy with rituximab (P < .0001) significantly decreased the HR of disease progression. CONCLUSIONS: The study confirmed the high efficacy and acceptable safety profile of induction therapy with RCC and maintenance therapy with rituximab in previously untreated patients with CLL.
RCT Entities:
OBJECTIVES: PALG CLL4 is the first, randomized, phase IIIb study with rituximab, cladribine, and cyclophosphamide (RCC) induction and subsequent maintenance with rituximab in previously untreated chronic lymphocytic leukemia (CLL) patients. METHODS: The induction treatment consisted of 6 RCC cycles regimen. Patients with complete response (CR) or partial response (PR) after an induction phase were randomized into a maintenance arm with rituximab or an observational arm. RESULTS: In the intention-to-treat population, 97 patients completed the induction phase with an overall response rate (ORR) of 73.2% (CR 22.7%, PR 50.5%). Subsequently, 66 patients were randomized into the rituximab maintenance arm (n = 33) or the observational arm (n = 33). CR rates were 57.1% in the maintenance group vs 50% in the observational group. PFS was significantly longer in the rituximab maintenance vs the observational arm (P = .028). The multivariate Cox model indicated that del17p (P = .006) and elevated beta-2-microglobulin (P = .015) significantly increased the hazard ratio (HR) of progression, whereas the presence of CD38 (P = .013) significantly decreased it; maintenance therapy with rituximab (P < .0001) significantly decreased the HR of disease progression. CONCLUSIONS: The study confirmed the high efficacy and acceptable safety profile of induction therapy with RCC and maintenance therapy with rituximab in previously untreated patients with CLL.
Authors: L Bergantini; M d'Alessandro; P Cameli; L Vietri; C Vagaggini; A Perrone; P Sestini; B Frediani; E Bargagli Journal: Clin Rheumatol Date: 2020-02-22 Impact factor: 2.980