Phase II study of lenalidomide and rituximab as salvage therapy for patients with relapsed or refractory chronic lymphocytic leukemia

Journal of Clinical Oncology

Volumn 31, Issue 5, 2013, Pages 584-591

  Badoux, Xavier C ^a   Keating, Michael J ^a   Wen, Sijin ^a   Wierda, William G ^a   O'Brien, Susan M ^a   Faderl, Stefan ^a   Sargent, Rachel ^a   Burger, Jan A ^a   Ferrajoli, Alessandra ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LENALIDOMIDE; RITUXIMAB;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; DRUG EFFICACY; FEMALE; HUMAN; KIDNEY FAILURE; LYMPHATIC LEUKEMIA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOEMBOLISM; TREATMENT FAILURE; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; FEVER; HUMANS; IMMUNOLOGIC FACTORS; INFECTION; KAPLAN-MEIER ESTIMATE; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; NEOPLASM STAGING; RECURRENCE; SALVAGE THERAPY; THALIDOMIDE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84875451856     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.42.8623     Document Type: Article

References (44)

1. Hallek M, Fischer K, Fingerle-Rowson G, et al: Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: A randomised, open-label, phase 3 trial. Lancet 376: 1164-1174, 2010
2. Tam CS, O'Brien S, Wierda W, et al: Longterm results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood 112: 975-980, 2008
3. Badoux XC, Keating MJ, Wang X, et al: Fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy is highly effective treatment for relapsed patients with CLL. Blood 117: 3016-3024, 2011
4. Bergmann MA, Goebeler ME, Herold M, et al: Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: Results of a phase I/II study of the German CLL Study Group. Haematologica 90: 1357-1364, 2005 (Pubitemid 41503651)
5. Iannitto E, Morabito F, Mancuso S, et al: Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia: An Italian retrospective study. Br J Haematol 153:351- 357, 2011
6. Robak T, Dmoszynska A, Solal-Céligny P, et al: Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol 28: 1756-1765, 2010
7. Fischer K, Cramer P, Busch R, et al: Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: A multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol 29: 3559-3566, 2011
8. Tsimberidou AM, Keating MJ: Treatment of patients with fludarabine-refractory chronic lymphocytic leukemia: Need for new treatment options. Leuk Lymphoma 51: 1188-1199, 2010
9. Keating MJ, Flinn I, Jain V, et al: Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: Results of a large international study. Blood 99: 3554-3561, 2002 (Pubitemid 34534522)
10. Wierda WG, Kipps TJ, Mayer J, et al: Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 28: 1749-1755, 2010
11. Stilgenbauer S, Zenz T, Winkler D, et al: Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: Clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol 27: 3994-4001, 2009
12. Keating M, Coutré S, Rai K, et al: Management guidelines for use of alemtuzumab in B-cell chronic lymphocytic leukemia. Clin Lymphoma 4: 220-227, 2004 (Pubitemid 38528876)
13. Wu L, Adams M, Carter T, et al: Lenalidomide enhances natural killer cell and monocyte-mediated antibody-dependent cellular cytotoxicity of rituximabtreated CD20- tumor cells. Clin Cancer Res 14: 4650-4657, 2008
14. Aue G, Njuguna N, Tian X, et al: Lenalidomideinduced upregulation of CD80 on tumor cells correlates with T-cell activation, the rapid onset of a cytokine release syndrome and leukemic cell clearance in chronic lymphocytic leukemia. Haematologica 94: 1266-1273, 2009
15. Chanan-Khan AA, Cheson BD: Lenalidomide for the treatment of B-cell malignancies. J Clin Oncol 26: 1544-1552, 2008
16. Lapalombella R, Andritsos L, Liu Q, et al: Lenalidomide treatment promotes CD154 expression on CLL cells and enhances production of antibodies by normal B cells through a PI3-kinase-dependent pathway. Blood 115: 2619-2629, 2010
17. Lee BN, Gao H, Cohen EN, et al: Treatment with lenalidomide modulates T-cell immunophenotype and cytokine production in patients with chronic lymphocytic leukemia. Cancer 117:3999- 4008, 2011
18. Reddy N, Hernandez-Ilizaliturri FJ, Deeb G, et al: Immunomodulatory drugs stimulate natural killercell function, alter cytokine production by dendritic cells, and inhibit angiogenesis enhancing the antitumour activity of rituximab in vivo. Br J Haematol 140: 36-45, 2008 (Pubitemid 350233246)
19. Ramsay AG, Gribben JG: Immune dysfunction in chronic lymphocytic leukemia T cells and lenalidomide as an immunomodulatory drug. Haematologica 94: 1198-1202, 2009
20. Ramsay AG, Johnson AJ, Lee AM, et al: Chronic lymphocytic leukemia T cells show impaired immunological synapse formation that can be reversed with an immunomodulating drug. J Clin Invest 118: 2427-2437, 2008 (Pubitemid 351949771)
21. Chanan-Khan A, Miller KC, Musial L, et al: Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: Results of a phase II study. J Clin Oncol 24:5343- 5349, 2006 (Pubitemid 46623164)
22. Andritsos LA, Johnson AJ, Lozanski G, et al: Higher doses of lenalidomide are associated with unacceptable toxicity including life-threatening tumor flare in patients with chronic lymphocytic leukemia. J Clin Oncol 26: 2519-2525, 2008
23. Chen CI, Bergsagel PL, Paul H, et al: Singleagent lenalidomide in the treatment of previously untreated chronic lymphocytic leukemia. J Clin Oncol 29: 1175-1181, 2011
24. Ferrajoli A, Lee BN, Schlette EJ, et al: Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. Blood 111: 5291-5297, 2008
25. Cheson BD, Bennett JM, Grever M, et al: National Cancer Institute-sponsored working group guidelines for chronic lymphocytic leukemia: Revised guidelines for diagnosis and treatment. Blood 87: 4990-4997, 1996 (Pubitemid 26189840)
26. 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 111:5446- 5456, 2008
27. Rassenti LZ, Huynh L, Toy TL, et al: ZAP-70 compared with immunoglobulin heavy-chain gene mutation status as a predictor of disease progression in chronic lymphocytic leukemia. N Engl J Med 351: 893-901, 2004 (Pubitemid 39096916)
28. Smith TJ, Khatcheressian J, Lyman GH, et al: 2006 update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline. J Clin Oncol 24:3187- 3205, 2006 (Pubitemid 46638957)
29. Badoux XC, Keating MJ, Wen S, et al: Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood 118:3489- 3498, 2011
30. Sher T, Miller KC, Lawrence D, et al: Efficacy of lenalidomide in patients with chronic lymphocytic leukemia with high-risk cytogenetics. Leuk Lymphoma 51: 85-88, 2010
31. Knauf W, Rieger K, Blau W, et al: Remission induction using alemtuzumab can permit chemotherapy- refractory chronic lymphocytic leukemia (CLL) patients to undergo allogeneic stem cell transplantation. Leuk Lymphoma 45: 2455-2458, 2004 (Pubitemid 40081189)
32. Byrd JC, Murphy T, Howard RS, et al: Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol 19: 2153-2164, 2001 (Pubitemid 32366969)
33. O'Brien SM, Kantarjian H, Thomas DA, et al: Rituximab dose-escalation trial in chronic lymphocytic leukemia. J Clin Oncol 19: 2165-2170, 2001 (Pubitemid 32366970)
34. Bowen DA, Call TG, Jenkins GD, et al: Methylprednisolone-rituximab is an effective salvage therapy for patients with relapsed chronic lymphocytic leukemia including those with unfavorable cytogenetic features. Leuk Lymphoma 48: 2412-2417, 2007 (Pubitemid 350253473)
35. Castro JE, Sandoval-Sus JD, Bole J, et al: Rituximab in combination with high-dose methylprednisolone for the treatment of fludarabine refractory high-risk chronic lymphocytic leukemia. Leukemia 22: 2048-2053, 2008
36. Keating MJ, Wierda WG, Tam CS, et al: Long-term outcome following treatment failure of FCR chemoimmunotherapy as initial therapy for chronic lymphocytic leukemia. Blood 114, 2009 (abstr 2381)
37. Moutouh-de Parseval LA, Weiss L, DeLap RJ, et al: Tumor lysis syndrome/tumor flare reaction in lenalidomide-treated chronic lymphocytic leukemia. J Clin Oncol 25:5047, 2007 (Pubitemid 350220451)
38. Coiffier B, Altman A, Pui CH, et al: Guidelines for the management of pediatric and adult tumor lysis syndrome: An evidence-based review. J Clin Oncol 26: 2767-2778, 2008
39. Wendtner C, Hillmen P, Mahadevan D, et al: Final results of the phase I study of lenalidomide in patients with relapsed/refractory chronic lymphocytic leukemia (CLL-001 study). Blood 116, 2010 (abstr 1376)
40. Wendtner C, Fraser G, Goldberg SL, et al: Interim results for the safety and efficacy of different lenalidomide starting dose regimens in subjects with relapsed or refractory chronic lymphocytic leukemia (CC-5013-CLL- 009 study). Blood 118, 2011 (abstr 2859)
41. Miller KC, Musial L, Whitworth A, et al: Management of patients with chronic lymphocytic leukemia treated with lenalidomide. Clin J Oncol Nurs 14: 491-499, 2010
42. Dimopoulos MA, Richardson PG, Brandenburg N, et al: A review of second primary malignancy in patients with relapsed or refractory multiple myeloma treated with lenalidomide. Blood 119: 2764-2767, 2012
43. Morton LM, Curtis RE, Linet MS, et al: Second malignancy risks after non-Hodgkin's lymphoma and chronic lymphocytic leukemia: Differences by lymphoma subtype. J Clin Oncol 28: 4935-4944, 2010
44. Tsimberidou AM, Wen S, McLaughlin P, et al: Other malignancies in chronic lymphocytic leukemia/ small lymphocytic lymphoma. J Clin Oncol 27: 904-910, 2009