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- Title
Rituximab, cladribine, and cyclophosphamide (RCC) induction with rituximab maintenance in chronic lymphocytic leukemia: PALG ‐ CLL4 (ML21283) trial.
- Authors
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
- Abstract
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 (<italic>P</italic> = .028). The multivariate Cox model indicated that del17p (<italic>P</italic> = .006) and elevated beta‐2‐microglobulin (<italic>P</italic> = .015) significantly increased the hazard ratio (HR) of progression, whereas the presence of CD38 (<italic>P</italic> = .013) significantly decreased it; maintenance therapy with rituximab (<italic>P</italic> < .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.
- Subjects
RITUXIMAB; CYCLOPHOSPHAMIDE; CHRONIC lymphocytic leukemia; CLINICAL trials; RANDOMIZED controlled trials
- Publication
European Journal of Haematology, 2018, Vol 100, Issue 5, p465
- ISSN
0902-4441
- Publication type
Article
- DOI
10.1111/ejh.13042