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Rituximab, cladribine, and cyclophosphamide (RCC) induction with rituximab maintenance in chronic lymphocytic leukemia: PALG ‐ CLL4 ( ML 21283) trial
Author(s) -
Robak Tadeusz,
Błoński Jerzy,
Skotnicki Aleksander Bartłomiej,
Piotrowska Magdalena,
Wróbel Tomasz,
Rybka Justyna,
Kłoczko Janusz,
Bołkun Łukasz,
Budziszewska Bożena Katarzyna,
Walczak Urszula,
Uss Anatoly,
Fidecka Marta,
Smolewski Piotr
Publication year - 2018
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.13042
Subject(s) - rituximab , medicine , maintenance therapy , hazard ratio , chronic lymphocytic leukemia , gastroenterology , cyclophosphamide , regimen , randomized controlled trial , population , cladribine , induction chemotherapy , oncology , surgery , leukemia , chemotherapy , confidence interval , lymphoma , environmental health
Objectives PALG CLL 4 is the first, randomized, phase III b 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 CD 38 ( 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 .