Magdalena Piotrowska

Ofatumumab As Single-Agent CD20 Immunotherapy in Fludarabine-Refractory Chronic Lymphocytic Leukemia

PURPOSE New treatments are needed for patients with fludarabine- and alemtuzumab-refractory (FA-ref) chronic lymphocytic leukemia (CLL) or patients with fludarabine-refractory CLL with bulky (> 5 cm) lymphadenopathy (BF-ref) who are less suitable for alemtuzumab treatment; these groups have poor outcomes with available salvage regimens. Ofatumumab (HuMax-CD20) is a human monoclonal antibody targeting a distinct small-loop epitope on the CD20 molecule. We conducted an international clinical study to evaluate the efficacy and safety of ofatumumab in patients with FA-ref and BF-ref CLL. PATIENTS AND METHODS Patients received eight weekly infusions of ofatumumab followed by four monthly infusions during a 24-week period (dose 1 = 300 mg; doses 2 to 12 = 2,000 mg); response by an independent review committee (1996 National Cancer Institute Working Group criteria) was assessed every 4 weeks until week 24 and then every 3 months until month 24. RESULTS This planned interim analysis included 138 treated patients with FA-ref (n = 59) and BF-ref (n = 79) CLL. The overall response rates (primary end point) were 58% [corrected] and 47% in the FA-ref and BF-ref groups, respectively. Complete resolution of constitutional symptoms and improved performance status occurred in 57% and 48% of patients, respectively. Median progression-free survival and overall survival times were 5.7 and 13.7 months in the FA-ref group, respectively, and 5.9 and 15.4 months in the BF-ref group, respectively. The most common adverse events during treatment were infusion reactions and infections, which were primarily grade 1 or 2 events. Hematologic events during treatment included anemia and neutropenia. CONCLUSION Ofatumumab is an active, well-tolerated treatment providing clear clinical improvements for fludarabine-refractory patients with very poor-prognosis CLL.

Ofatumumab monotherapy in fludarabine-refractory chronic lymphocytic leukemia: final results from a pivotal study

While fludarabine-based regimens are a standard for treatment of chronic lymphocytic leukemia (CLL), patients who become refractory to fludarabine have had low response rates with salvage therapy and poor survival outcomes.[1][1]–[3][2] We reported that ofatumumab, a human monoclonal antibody that

Efficacy and toxicity of compassionate ibrutinib use in relapsed/refractory chronic lymphocytic leukemia in Poland: analysis of the Polish Adult Leukemia Group (PALG)

El_ zbieta Iskierka-Ja_ zd_ zewska, Marek Hus, Krzysztof Giannopoulos, El_ zbieta Mądro, Jadwiga Hołojda, Magdalena Piotrowska, Jan M. Zaucha, Weronika Piszczek, Agnieszka Szeremet, Małgorzata Wojciechowska, Paweł Steckiewicz, Wanda Knopi nska-Posłuszny, Marek Osowiecki, Joanna Drozd-Sokołowska, Beata Kumiega, Sławomira Kyrcz-Krzemie n, Janusz Hałka, Marek Dudzi nski, Paulina Wieszczy, Tadeusz Robak, Krzysztof Warzocha and Krzysztof Jamroziak Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland; Department of Haematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland; Experimental Hematooncology Department, Medical University of Lublin & Hematology Department, St. Johns Cancer Center, Lublin, Poland; Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland; Department of Hematology, Specialist District Hospital, Legnica, Poland; Department of Hematology, Cracow University Hospital, Cracow, Poland; Department of Oncological Propaedeutics, Medical University of Gdansk, Gdansk, Poland & Gdynia Oncology Center, Gdynia, Poland; Department of Hematology, Copernicus Hospital, Torun, Poland; Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland; Department of Hematology, Specialist District Hospital, Olsztyn, Poland; Department of Hematology, Holycross Cancer Center, Kielce, Poland; Department of Hematology, Independent Public Health Care of the Ministry of the Internal Affairs with the Oncology Centre, Olsztyn, Poland; Department of Lymphoid Malignancies, Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warsaw, Poland; Department of Hematology, Oncology and Internal Diseases, Medical University of Warsaw, Warsaw, Poland; Department of Haematooncology, Oncology Centre of the Podkarpackie Province, Brzozow, Poland; Department of Hematology and Bone Marrow Transplantation, Silesian Medical University Hospital SPSKM, Katowice, Poland; Department of Hematology, Military Institute of Medicine, Warsaw, Poland; Department of Hematology, Specialist District Hospital, Rzeszow, Poland; Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Center for Postgraduate Education, Warsaw, Poland

Long-term results of the Polish Adult Leukemia Group PALG-CLL2 phase III randomized study comparing cladribine-based combinations in chronic lymphocytic leukemia

Abstract Long-term outcomes following newer therapies for chronic lymphocytic leukemia (CLL) have rarely been reported. This article presents the results of the final analysis of the Polish Adult Leukemia Group PALG-CLL2 study performed 10 years from final patient enrollment. With the extended follow-up time, it was found that cladribine (2-CdA)-based combinations CMC (2-CdA, cyclophosphamide, mitoxantrone) and CC (2-CdA, cyclophosphamide) administered as first-line treatment of progressive CLL resulted in significantly longer progression-free survival, but similar overall survival compared to 2-CdA monotherapy. Furthermore, the risk of potentially fatal late adverse events including infections, autoimmune complications and, particularly, secondary neoplasms was comparable among patients treated with CMC, CC or 2-CdA. The results of our analysis support the importance of long-term outcome monitoring of randomized trials in CLL.

Rituximab, cladribine, and cyclophosphamide (RCC) induction with rituximab maintenance in chronic lymphocytic leukemia: PALG - CLL4 (ML21283) trial

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.