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Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia
| Content Provider | Scilit |
|---|---|
| Author | Wierda, William G. Kipps, Thomas J. Dürig, Jan Griskevicius, Laimonas Stilgenbauer, Stephan Mayer, Jiří Smolej, Lukas Hess, Georg Griniute, Rasa Hernandez-Ilizaliturri, Francisco J. Padmanabhan, Swaminathan Gorczyca, Michele Chang, Chai-Ni Chan, Geoffrey Gupta, Ira Nielsen, Tina G. Russell, Charlotte A. |
| Copyright Year | 2011 |
| Description | We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n = 31) or 1000 mg (n = 30) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts. The median age was 56 years; 13% of patients had a 17p deletion; 64% had β2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively. Based on univariable regression analyses, β2-microglobulin and the number of O-FC courses were significantly correlated (P < .05) with CR and OR rates and progression-free survival (PFS). The most frequent Common Terminology Criteria (CTC) grade 3-4 investigator-reported adverse events were neutropenia (48%), thrombocytopenia (15%), anemia (13%), and infection (8%). O-FC is active and safe in treatment-naive patients with CLL, including high-risk patients. This trial was registered at www.clinicaltrials.gov as NCT00410163. |
| Related Links | http://www.bloodjournal.org/content/bloodjournal/117/24/6450.full.pdf |
| Ending Page | 6458 |
| Page Count | 9 |
| Starting Page | 6450 |
| DOI | 10.1182/blood-2010-12-323980 |
| Journal | Blood |
| Issue Number | 24 |
| Volume Number | 117 |
| Language | English |
| Publisher | American Society of Hematology |
| Publisher Date | 2011-06-16 |
| Access Restriction | Open |
| Subject Keyword | Hematology Anemia Neutropenia Complete Response Ofatumumab Cll Thrombocytopenia Chronic Lymphocytic Leukemia Journal: Blood (Vol- 138, Issue- 24) |
| Content Type | Text |
| Resource Type | Article |
