Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG): An open-label, multicentre, randomised phase 3 study

The Lancet Oncology

Volumn 16, Issue 13, 2015, Pages 1370-1379

  van Oers, Marinus H J ^a,b   Kuliczkowski, Kazimierz ^c   Smolej, Lukáš ^d   Petrini, Mario ^e   Offner, Fritz ^f   Grosicki, Sebastian ^g   Levin, Mark David ^b,h   Gupta, Ira ⁱ   Phillips, Jennifer ⁱ   Williams, Vanessa ⁱ   Manson, Stephanie ^c   Lisby, Steen ^j   Geisler, Christian ^k  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b The Haemato Oncology Foundation for Adults in the Netherlands (HOVON)   (Netherlands)

^c Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu ^*  (United Kingdom)

^d CHARLES UNIVERSITY   (Czech Republic)

^e UNIVERSITY HOSPITAL OF PISA   (Italy)

^f GHENT UNIVERSITY HOSPITAL   (Belgium)

^g MEDICAL UNIVERSITY OF SILESIA   (Poland)

^h ALBERT SCHWEITZER HOSPITAL   (Netherlands)

ⁱ GLAXOSMITHKLINE   (United States)

^j Genmab   (Denmark)

^k University of Copenhagen   (Denmark)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; IMMUNOGLOBULIN M; OFATUMUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BRONCHITIS; CANCER GROWTH; CANCER RECURRENCE; CANCER REGRESSION; CAUSE OF DEATH; CHRONIC LYMPHATIC LEUKEMIA; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; HEADACHE; HEART ARREST; HERPES ZOSTER; HUMAN; HYPERTENSION; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOGLOBULIN DEFICIENCY; INFECTION; INFUSION RELATED REACTION; INSOMNIA; INTENTION TO TREAT ANALYSIS; INTERACTIVE VOICE RESPONSE SYSTEM; INTESTINE OBSTRUCTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; OBSERVATIONAL STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT INFECTION; SEPSIS; SINUSITIS; SUBDURAL HEMATOMA; THROMBOCYTOPENIA; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WEIGHT REDUCTION; ADVERSE EFFECTS; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE COURSE; DISEASE FREE SURVIVAL; KAPLAN MEIER METHOD; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; MORTALITY; PROCEDURES; RECURRENT DISEASE; RISK FACTOR; TIME; TREATMENT OUTCOME; VERY ELDERLY; WATCHFUL WAITING;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; KAPLAN-MEIER ESTIMATE; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; RECURRENCE; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; WATCHFUL WAITING;

EID: 84951907500     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00143-6     Document Type: Article

References (25)

1. Dreger P, Schetelig J, Andersen N, et al. Managing high-risk CLL during transition to a new treatment era: stem cell transplantation or novel agents?. Blood 2014, 124:3841-3849.
2. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet 2011, 377:42-51.
3. van Oers MH, Van GM, Giurgea L, et al. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol 2010, 28:2853-2858.
4. Vidal L, Gafter-Gvili A, Salles G, et al. Rituximab maintenance for the treatment of patients with follicular lymphoma: an updated systematic review and meta-analysis of randomized trials. J Natl Cancer Inst 2011, 103:1799-1806.
5. Shanafelt TD, Ramsay AG, Zent CS, et al. Long-term repair of T-cell synapse activity in a phase II trial of chemoimmunotherapy followed by lenalidomide consolidation in previously untreated chronic lymphocytic leukemia (CLL). Blood 2013, 121:4137-4141.
6. Maddocks K, Ruppert AS, Browning R, et al. A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia. Leuk Res 2014, 38:1025-1029.
7. Del Poeta G, Del Principe MI, Buccisano F, et al. Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia. Cancer 2008, 112:119-128.
8. Bo MD, Del Principe MI, Pozzo F, et al. NOTCH1 mutations identify a chronic lymphocytic leukemia patient subset with worse prognosis in the setting of a rituximab-based induction and consolidation treatment. Ann Hematol 2014, 93:1765-1774.
9. Foà R, Del Giudice I, Cuneo A, et al. Chlorambucil plus rituximab with or without maintenance rituximab as first-line treatment for elderly chronic lymphocytic leukemia patients. Am J Hematol 2014, 89:480-486.
10. Abrisqueta P, Villamor N, Terol MJ, et al. Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia. Blood 2013, 122:3951-3959.
11. Kaufman MS, Caramanica A, Janson D, et al. Alemtuzumab maintenance may safely prolong chemotherapy-free intervals in chronic lymphocytic leukemia. Med Oncol 2011, 28:532-538.
12. Schweighofer CD, Ritgen M, Eichhorst BF, et al. Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG). Br J Haematol 2009, 144:95-98.
13. Huang BT, Zeng QC, Zhao WH, Li BS, Chen RL How to determine post-FCR therapy for cytogenetic risk-tailored elderly patients with chronic lymphocytic leukemia, maintenance rituximab or observation. Med Oncol 2014, 31:104.
14. Teeling JL, Mackus WJ, Wiegman LJ, et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol 2006, 177:362-371.
15. Barth MJ, Hernandez-Ilizaliturri FJ, Mavis C, et al. Ofatumumab demonstrates activity against rituximab-sensitive and -resistant cell lines, lymphoma xenografts and primary tumour cells from patients with B-cell lymphoma. Br J Haematol 2012, 156:490-498.
16. Rafiq S, Butchar JP, Cheney C, et al. Comparative assessment of clinically utilized CD20-directed antibodies in chronic lymphocytic leukemia cells reveals divergent NK cell, monocyte, and macrophage properties. J Immunol 2013, 190:2702-2711.
17. Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010, 28:1749-1755.
18. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008, 111:5446-5456.
19. Rawstron AC, Villamor N, Ritgen M, et al. International standardized approach for flow cytometric residual disease monitoring in chronic lymphocytic leukaemia. Leukemia 2007, 21:956-964.
20. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
21. Norman GR, Sloan JA, Wyrwich KW Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41:582-592.
22. Greil R, Obrtlikova P, Smolej L, et al. Rituximab maintenance after chemoimmunotherapy induction in 1st and 2nd line improves progression free survival: planned interim analysis of the International Randomized AGMT-CLL8/a Mabtenance Trial. 56th ASH Annual Meeting and Exposition; San Fransisco, CA, USA; Dec 6-9, 2014. Abstract 642.
23. Komarova NL, Burger JA, Wodarz D Evolution of ibrutinib resistance in chronic lymphocytic leukemia (CLL). Proc Natl Acad Sci USA 2014, 111:13906-13911.
24. Woyach JA, Furman RR, Liu TM, et al. Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib. N Engl J Med 2014, 370:2286-2294.
25. Chang BY, Furman RR, Zapatka M, et al. Use of tumor genomic profiling to reveal mechanisms of resistance to the BTK inhibitor ibrutinib in chronic lymphocytic leukemia (CLL). Proc Am Soc Clin Oncol 2013, 31(suppl). abstr 7041.