Chemoimmunotherapy with GA101 plus chlorambucil in patients with chronic lymphocytic leukemia and comorbidity: Results of the CLL11 (BO21004) safety run-in

Leukemia

Volumn 27, Issue 5, 2013, Pages 1172-1174

  Goede, V ^a   Fischer, K ^a   Busch, R ^b   Jaeger, U ^c   Dilhuydy, M S ^d   Wickham, N ^e   De Guibert, S ^f   Ritgen, M ^g   Langerak, A W ^h   Bieska, G ⁱ   Engelke, A ^a   Humphrey, K ⁱ   Wenger, M ⁱ   Hallek, M ^a  

^a UNIVERSITY OF COLOGNE   (Germany)

^b TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d BORDEAUX UNIVERSITY HOSPITAL   (France)

^e UNIVERSITY OF ADELAIDE   (Australia)

^f RENNES UNIVERSITY HOSPITAL   (France)

^g UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^h ERASMUS MEDICAL CENTER   (Netherlands)

ⁱ F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORAMBUCIL; OBINUTUZUMAB;

ANEMIA; CHEMOTHERAPY; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL (TOPIC); COMORBIDITY; DRUG SAFETY; HUMAN; IMMUNOTHERAPY; INFECTION; INFUSION RELATED REACTION; LETTER; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PRIORITY JOURNAL; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, ALKYLATING; CHLORAMBUCIL; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE;

EID: 84877624236     PISSN: 08876924     EISSN: 14765551     Source Type: Journal    
DOI: 10.1038/leu.2012.252     Document Type: Letter

References (15)

1. Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 2010; 376: 1164-1174.
2. Woyach JA, Ruppert AS, Peterson B, Rai KR, Lin TS, Appelbaum FR et al. Impact of age on outcomes following initial therapy with various chemotherapy and chemoimmunotherapy regimens in patients with chronic lymphocytic leukemia (CLL): results of CALGB Studies. Blood 2011; 118: (abstract 289).
3. Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M et al. First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood 2009; 114: 3382-3391.
4. Hillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P et al. Rituximab plus chlorambucil In patients with CD20-positive B-Cell chronic lymphocytic leukemia (CLL): final response analysis of an Open-Label Phase II Study. Blood 2010; 116: (abstract 697).
5. Foa R, Ciolli S, Di Raimondo F, Del Poeta G, Lauria F, Forconi F et al. Rituximab plus chlorambucil as initial treatment for elderly patients with chronic lymphocytic leukemia (CLL): effect of pre-treatment biological characteristics and gene expression patterns on response to treatment. Blood 2011; 118: (abstract 294).
6. Mossner E, Brunker P, Moser S, Puntener U, Schmidt C, Herter S et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood 2010; 115: 4393-4402.
7. Dalle S, Reslan L, Besseyre de Horts T, Herveau S, Herting F, Plesa A et al. Preclinical studies on the mechanism of action and the anti-lymphoma activity of the novel anti-CD20 antibody GA101. Mol Cancer Ther 2011; 10: 178-185.
8. Patz M, Isaeva P, Forcob N, Muller B, Frenzel LP, Wendtner CM et al. Comparison of the in vitro effects of the anti-CD20 antibodies rituximab and GA101 on chronic lymphocytic leukaemia cells. Br J Haematol 2011; 152: 295-306.
9. Salles G, Morschhauser F, Lamy T, Milpied NJ, Thieblemont C, Tilly H et al. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood 2012; 119: 5126-5132.
10. Morschhauser F, Cartron G, Lamy T, Milpied N-J, Thieblemont C, Tilly H et al. Phase I Study of RO5072759 (GA101) in relapsed/refractory chronic lymphocytic leukemia. Blood 2009; 114: (abstract 884).
11. Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H 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.
12. Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc 1995; 43: 130-137.
13. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
14. Ritgen M, Bottcher S, Stilgenbauer S, Bunjes D, Schubert J, Cohen S et al. Quantitative MRD monitoring identifies distinct GVL response patterns after allogeneic stem cell transplantation for chronic lymphocytic leukemia: results from the GCLLSG CLL3X trial. Leukemia 2008; 22: 1377-1386.
15. Sehn LH, Assouline SE, Stewart DA, Mangel J, Gascoyne RD, Fine G et al. A phase I study of obinutuzumab induction followed by two years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood 2012; 119: 5118-5125.