Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

Blood

Volumn 115, Issue 3, 2010, Pages 489-495

  Byrd, John C ^a   Kipps, Thomas J ^b   Flinn, Ian W ^c   Castro, Januaro ^d   Lin, Thomas S ^a   Wierda, William ^e   Heerema, Nyla ^a   Woodworth, James ^f   Hughes, Steve ^f   Tangri, Shabnam ^f   Harris, Sarah ^f   Wynne, Dee ^f   Molina, Arturo ^f   Leigh, Bryan ^f   O'Brien, Susan ^e  

^a OHIO STATE UNIVERSITY   (United States)

^b UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^c Section of Medical Oncology   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^f BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLOPURINOL; CYCLOPHOSPHAMIDE; DIPHENHYDRAMINE; FLUDARABINE; GRANISETRON; LUMILIXIMAB; PARACETAMOL; RITUXIMAB; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; MONOCLONAL ANTIBODY; VIDARABINE;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BACKACHE; CANCER COMBINATION CHEMOTHERAPY; CANCER FATIGUE; CANCER IMMUNOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED EMESIS; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; CLOSTRIDIUM INFECTION; CONSTIPATION; COUGHING; CYTOMEGALOVIRUS INFECTION; CYTOPENIA; DIARRHEA; DIZZINESS; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG WITHDRAWAL; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; FLUSHING; HEMOLYTIC ANEMIA; HUMAN; HYPOKALEMIA; HYPOTENSION; INSOMNIA; LEUKEMIA RELAPSE; LEUKOPENIA; MALAISE; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCYTOPENIA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT RESPONSE; TREMOR; TUMOR LYSIS SYNDROME; UPPER RESPIRATORY TRACT INFECTION; WOUND INFECTION; BLOOD; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG EFFECT; DRUG RESISTANCE; METABOLISM; MIDDLE AGED; PATHOLOGY; RECURRENT DISEASE;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; RECURRENCE; VIDARABINE;

EID: 77449133613     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2009-08-237727     Document Type: Article

References (26)

1. Ries LAG, Melbert D, Krapcho M, et al, eds. SEER Cancer Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD. http://seer.cancer. gov/csr/1975-2004/, based on November 2006 SEER data submission, posted to the SEER web site, 2007. Accessed January 1, 2009.
2. Gowda A, Byrd JC. Use of prognostic factors in risk stratification at diagnosis and time of treatment of patients with chronic lymphocytic leukemia. Curr Opin Hematol. 2006;13(4):266-272.
3. Döhner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000;343(26): 1910-1916.
4. 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. 2004;351(9):893-901.
5. Damle RN, Wasil T, Fais F, et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia. Blood. 1999;94(6):1840-1847.
6. Rosenwald A, Alizadeh AA, Widhopf G, et al. Relation of gene expression phenotype to immunoglobulin mutation genotype in B cell chronic lymphocytic leukemia. J Exp Med. 2001;194(11): 1639-1647.
7. Grever MR, Lucas DM, Dewald GW, et al. Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from a prospective randomized US Intergroup Phase III Trial E2997. J Clin Oncol. 2007;25(7):799-804.
8. Byrd JC, Gribben JG, Peterson BL, et al. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J Clin Oncol. 2006;24(3):437-443.
9. Dohner H, Fischer K, Bentz M, et al. p53 gene deletion predicts for poor survival and nonresponse to therapy with purine analogs in chronic B-cell leukemias. Blood. 1995;85(6): 1580-1589.
10. Catovsky D, Richards S, Matutes E, et al. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet. 2007;370(9583):230-239.
11. Eichhorst BF, Busch R, Hopfinger G, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006; 107(3):885-891.
12. Flinn IW, Neuberg DS, Grever MR, et al. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007;25(7): 793-798.
13. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23(18):4079-4088.
14. Wierda W, O'Brien S, Wen S, et al. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol. 2005;23(18): 4070-4078.
15. Wierda W, O'Brien S, Faderl S, et al. A retrospective comparison of three sequential groups of patients with recurrent/refractory chronic lymphocytic leukemia treated with fludarabinebased regimens. Cancer. 2006;106(2):337-345.
16. Hallek M, Fingerle-Rowson G, Fink A-M, et al. Immunochemotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) versus fludarabine and cyclophosphamide (FC) improves response rates and progression-free survival (PFS) of previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL) [abstract]. Blood. 2008;112(111):325.
17. Robak T, Moiseev SI, Dmoszynska A, et al. Rituximab, fludarabine, and cyclophosphamide (R-FC) prolongs progression free survival in relapsed or refractory chronic lymphocytic leukemia (CLL) compared with fc alone: final results from the International Randomized Phase III REACH Trial [abstract]. Blood. 2008;112 (111):LBA-1.
18. Hulkkonen J, Vilpo L, Hurme M, Vilpo J. Surface antigen expression in chronic lymphocytic leukemia: clustering analysis, interrelationships and effects of chromosomal abnormalities. Leukemia. 2002;16(2):178-185.
19. Gong JZ, Lagoo AS, Peters D, Horvatinovich J, Benz P, Buckley PJ. Value of CD23 determination by flow cytometry in differentiating mantle cell lymphoma from chronic lymphocytic leukemia/ small lymphocytic lymphoma. Am J Clin Pathol. 2001;116(6):893-897.
20. Pathan NI, Chu P, Hariharan K, Cheny C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008;111(3):1594-1602.
21. Byrd JC, O'Brien S, Flinn IW, et al. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007;13(15 pt 1):4448-4455.
22. 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. 1996;87(12):4990-4997.
23. Byrd JC, Smith L, Hackbarth ML, et al. Interphase cytogenetic abnormalities in chronic lymphocytic leukemia may predict response to rituximab. Cancer Res. 2003;63(1):36-38.
24. Byrd JC, Peterson B, Piro L, et al. A phase II study of cladribine treatment for fludarabine refractory B cell chronic lymphocytic leukemia: results from CALGB Study 9211. Leukemia. 2003; 17(2):323-327.
25. Rituxan (Rituximab) [Package Insert]. South San Francisco, CA: Genentech Inc; 2008.
26. Campath (Alemtuzumab) [Package Insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals; 2007.