Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin’s lymphoma

Annals of Hematology

Volumn 94, Issue 4, 2015, Pages 633-641

  Czuczman, Myron S ^a   Kahanic, Stephen ^b   Forero, Andres ^c   Davis, Glen ^d   Munteanu, Mihaela ^d   Van Den Neste, Eric ^e   Offner, Fritz ^f   Bron, Dominique ^g   Quick, Donald ^h   Fowler, Nathan ⁱ  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

^b Siouxland Hematology Oncology Associates   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d Teva Branded Pharmaceutical Products RandD Inc   (United States)

^e CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^f GHENT UNIVERSITY HOSPITAL   (Belgium)

^g JULES BORDET INSTITUTE   (Belgium)

^h Joe Arrington Cancer Center   (United States)

ⁱ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

(6 max) Bendamustine; B cell lymphoma; FDG PET; Non Hodgkin s lymphoma; Ofatumumab

Indexed keywords

BENDAMUSTINE; OFATUMUMAB; ANTINEOPLASTIC AGENT; CHLORMETHINE DERIVATIVE; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; B CELL LYMPHOMA; BACKACHE; CANCER CHEMOTHERAPY; CHILL; CONSTIPATION; COUGHING; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; FOLLICULAR LYMPHOMA; HUMAN; HYPERGLYCEMIA; HYPERTENSION; INFUSION RELATED REACTION; INSOMNIA; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MARGINAL ZONE LYMPHOMA; MULTICENTER STUDY; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NEUTROPENIA; NODAL MARGINAL ZONE LYMPHOMA; OPEN STUDY; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; SEPSIS; TACHYCARDIA; THROMBOCYTOPENIA; URTICARIA; VOMITING; WALDENSTROEM MACROGLOBULINEMIA; ADJUVANT THERAPY; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; LYMPHOMA, B-CELL; MIDDLE AGED; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; LYMPHOMA, B-CELL; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NITROGEN MUSTARD COMPOUNDS; TREATMENT OUTCOME;

EID: 84925496626     PISSN: 09395555     EISSN: 14320584     Source Type: Journal    
DOI: 10.1007/s00277-014-2269-8     Document Type: Article

References (14)

1. Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W, Study group indolent Lymphomas (StiL) (2013) Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet 381:1203–1210. doi:10.1016/S0140-6736(12)61763-2
2. Czuczman MS, Grillo-López AJ, White CA, Saleh M, Gordon L, LoBuglio AF, Jonas C, Klippenstein D, Dallaire B, Varns C (1999) Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol 17:268–276
3. Marcus R, Imrie K, Belch A, Cunningham D, Flores E, Catalano J, Solal-Celigny P, Offner F, Walewski J, Raposo J, Jack A, Smith P (2005) CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood 105:1417–1423
4. Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM (2014) Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood 123:2944–2952. doi:10.1182/blood-2013-11-531327
5. Leoni LM, Bailey B, Reifert J, Bendall HH, Zeller RW, Corbeil J, Elliott G, Niemeyer CC (2008) Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res 14:309–317. doi:10.1158/1078-0432.CCR-07-1061
6. Tageja N (2011) Bendamustine: safety and efficacy in the management of indolent non-Hodgkin’s lymphoma. Clin Med Insights Oncol 5:145–156. doi:10.4137/CMO.S6085
7. Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A, 409 Study Investigators (2012) Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol 157:438–445. doi:10.1111/j.1365-2141.2012.09086.×
8. Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J (2008) First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood 111:5486–5495. doi:10.1182/blood-2007-10-117671
9. Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, Keegan P, Pazdur R (2010) U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab. Clin Cancer Res 16:4331–4338. doi:10.1158/1078-0432.CCR-10-0570
10. Teeling JL, French RR, Cragg MS, van den Brakel J, Pluyter M, Huang H, Chan C, Parren PW, Hack CE, Dechant M, Valerius T, van de Winkel JG, Glennie MJ (2004) Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood 104:1793–1800
11. Teeling JL, Mackus WJ, Wiegman LJ, van den Brakel JH, Beers SA, French RR, van Meerten T, Ebeling S, Vink T, Slootstra JW, Parren PW, Glennie MJ, van de Winkel JG (2006) The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol 177:362–371
12. Czuczman MS, Fayad L, Delwail V, Cartron G, Jacobsen E, Kuliczkowski K, Link BK, Pinter-Brown L, Radford J, Hellmann A, Gallop-Evans E, DiRienzo CG, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Schultz M, Russell CA, Hagenbeek A, 405 Study Investigators (2012) Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study. Blood 119:3698–3704. doi:10.1182/blood-2011-09-378323
13. Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16:139–144
14. Trotman J, Fournier M, Lamy T, Seymour JF, Sonet A, Janikova A, Shpilberg O, Gyan E, Tilly H, Estell J, Forsyth C, Decaudin D, Fabiani B, Gabarre J, Salles B, Van Den Neste E, Canioni D, Garin E, Fulham M, Vander Borght T, Salles G (2011) Positron emission tomography–computed tomography (PET-CT) after induction therapy is highly predictive of patient outcome in follicular lymphoma: analysis of PET-CT in a subset of PRIMA trial participants. J Clin Oncol 29:3194–3200. doi:10.1200/JCO.2011.35.0736