Phase I trial of a novel human monoclonal antibody mab216 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia

Haematologica

Volumn 97, Issue 1, 2012, Pages 30-37

  Liedtke, Michaela ^a   Twist, Clare J ^a   Medeiros, Bruno C ^a   Gotlib, Jason R ^a   Berube, Caroline ^a   Bieber, Marcia M ^a   Bhat, Neelima M ^a   Teng, Nelson N ^a   Coutre, Steven E ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Antibody 216; B cell acute lymphoblastic leukemia; Refractory; Relapsed

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY 216; UNCLASSIFIED DRUG; VINCRISTINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; AGED; ARTICLE; B CELL LEUKEMIA; BLAST CELL; BLOOD TOXICITY; BONE MARROW HYPOPLASIA; CHILD; CLINICAL ARTICLE; COHORT ANALYSIS; DRUG BINDING; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG RESPONSE; DRUG TARGETING; DRUG TOLERABILITY; EPISTAXIS; FEMALE; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PRURITUS; SCHOOL CHILD; SEPSIS; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT; URTICARIA;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEUTRALIZING; ANTIGEN-ANTIBODY COMPLEX; ANTINEOPLASTIC AGENTS; CHILD; ERYTHROCYTES; FEMALE; HUMANS; MALE; MIDDLE AGED; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; RECURRENCE; TREATMENT OUTCOME; VINCRISTINE; YOUNG ADULT;

EID: 84855213868     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2011.045997     Document Type: Article

References (30)

1. Pui CH, Evans WE. Treatment of acute lymphoblastic leukemia. N Engl J Med. 2006;354(2):166-78.
2. Larson RA. The U.S. trials in adult acute lymphoblastic leukemia. Ann Hematol. 2004;83 (Suppl 1):S127-8.
3. Saarinen-Pihkala UM, Heilmann C, Winiarski J, Glomstein A, Abrahamsson J, Arvidson J, et al. Pathways through relapses and deaths of children with acute lym-phoblastic leukemia: role of allogeneic stem-cell transplantation in Nordic data. J Clin Oncol. 2006;24(36):5750-62.
4. Fielding AK, Richards SM, Chopra R, Lazarus HM, Litzow MR, Buck G, et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2007;109(3):944-50.
5. Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346(4):235-42.
6. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-84.
7. Raetz EA, Cairo MS, Borowitz MJ, Blaney SM, Krailo MD, Leil TA, et al. Chemo -immunotherapy reinduction with epratuzumab in children with acute lym-phoblastic leukemia in marrow relapse: a Children's Oncology Group Pilot Study. J Clin Oncol. 2008;26(22):3756-62.
8. Thomas DA, O'Brien S, Kantarjian HM. Monoclonal antibody therapy with ritux-imab for acute lymphoblastic leukemia. Hematol Oncol Clin North Am. 2009;23(5): 949-71.
9. Zwaan CM, Reinhardt D, Jurgens H, Huismans DR, Hahlen K, Smith O P, et al. Gemtuzumab ozogamicin in pediatric CD33-positive acute lymphoblastic leukemia: first clinical experiences and relation with cellular sensitivity to single agent calicheamicin. Leukemia. 2003;17(2):468-70.
10. Stock W, Yu D, Sanford B, et al. Incorporation of alemtuzumab into frontline therapy of adult acute lymphoblastic leukemia (ALL) is feasible: A Phase I/II Study from the Cancer and Leukemia Group B (CALGB 10102) ASH Annual Meeting Abstracts. Blood 106:145.
11. Roelcke D. Cold agglutination. Transfus Med Rev. 1989;3(2):140-66.
12. Silberstein LE, Jefferies LC, Goldman J, Friedman D, Moore JS, Nowell PC, et al. Variable region gene analysis of pathologic human autoantibodies to the related i and I red blood cell antigens. Blood. 1991;78(9): 2372-86.
13. Grillot-Courvalin C, Brouet JC, Piller F, Rassenti LZ, Labaume S, Silverman GJ, et al. An anti-B cell autoantibody from Wiskott-Aldrich syndrome which recognizes i blood group specificity on normal human B cells. Eur J Immunol. 1992;22(7): 1781-8.
14. Bhat NM, Bieber MM, Stevenson FK, Teng NN. Rapid cytotoxicity of human B lymphocytes induced by VH4-34 (VH4.21) gene-encoded monoclonal antibodies. Clin Exp Immunol. 1996;105(1):183-90.
15. Parr TB, Johnson TA, Silberstein LE, Kipps TJ. Anti-B cell autoantibodies encoded by VH 4-21 genes in human fetal spleen do not require in vivo somatic selection. Eur J Immunol. 1994;24(12):2941-9.
16. Inaba N, Hiruma T, Togayachi A, Iwasaki H, Wang XH, Furukawa Y, et al. A novel I-branching beta-1,6-N-acetylglucosaminyl -transferase involved in human blood group I antigen expression. Blood. 2003;101(7): 2870-6.
17. Yu LC, Twu YC, Chang CY, Lin M. Molecular basis of the adult i phenotype and the gene responsible for the expression of the human blood group I antigen. Blood. 2001;98(13):3840-5.
18. Bhat NM, Bieber MM, Hsu FJ, Chapman CJ, Spellerberg M, Stevenson FK, et al. Rapid cytotoxicity of human B lymphocytes induced by VH4-34 (VH4.21) gene-encoded monoclonal antibodies, II. Clin Exp Immunol. 1997;108(1):151-9.
19. Bhat NM, Bieber MM, Young LW, Teng NN. Susceptibility of B-cell lymphoma to human antibodies encoded by the V4-34 gene. Crit Rev Oncol Hematol. 2001;39(1-2):59-68.
20. Bieber MM, Twist CJ, Bhat NM, Teng NN. Effects of human monoclonal antibody 216 on B-progenitor acute lymphoblastic leukemia in vitro. Pediatr Blood Cancer. 2007;48(4):380-6.
21. Glasky MS, Yin A, Smith LH, Bieber M, Teng NN. Adenocarcinoma-reactive human monoclonal antibody MS2B6 defines an antigen in simple glandular epithelium. Hum Antibodies Hybridomas. 1992;3(3): 114-22.
22. Kantarjian HM, Gandhi V, Kozuch P, Faderl S, Giles F, Cortes J, et al. Phase I clinical and pharmacology study of clofarabine in patients with solid and hematologic cancers. J Clin Oncol. 2003;21(6):1167-73.
23. Einsiedel HG, von Stackelberg A, Hartmann R, Fengler R, Schrappe M, Janka-Schaub G, et al. Long-term outcome in children with relapsed ALL by risk-stratified salvage therapy: results of trial acute lym-phoblastic leukemia-relapse study of the Berlin-Frankfurt-Munster Group 87. J Clin Oncol. 2005;23(31):7942-50.
24. Herrera L, Bostrom B, Gore L, Sandler E, Lew G, Schlegel PG, et al. A phase 1 study of Combotox in pediatric patients with refractory B-lineage acute lymphoblastic leukemia. J Pediatr Hematol Oncol. 2009;31(12):936-41.
25. O'Brien MM, Lacayo NJ, Lum BL, Kshirsagar S, Buck S, Ravindranath Y, et al. Phase I study of valspodar (PSC-833) with mitoxantrone and etoposide in refractory and relapsed pediatric acute leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010;54(5): 694-702.
26. Thomas DA, Kantarjian HM, Stock W, Heffner LT, Faderl S, Garcia-Manero G, et al. Phase 1 multicenter study of vincristine sulfate liposomes injection and dexametha-sone in adults with relapsed or refractory acute lymphoblastic leukemia. Cancer. 2009;115(23):5490-8.
27. Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, 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):4448-55.
28. Angiolillo AL, Yu AL, Reaman G, Ingle AM, Secola R, Adamson PC. A phase II study of Campath-1H in children with relapsed or refractory acute lymphoblastic leukemia: a Children's Oncology Group report. Pediatr Blood Cancer. 2009;53(6):978-83.
29. Irie R F, Ollila DW, O'Day S, Morton DL. Phase I pilot clinical trial of human IgM monoclonal antibody to ganglioside GM3 in patients with metastatic melanoma. Cancer Immunol Immunother. 2004;53(2): 110-7.
30. Lin TS, Stock W, Xu H, Phelps MA, Lucas MS, Guster SK, et al. A phase I/II dose escalation study of apolizumab (Hu1D10) using a stepped-up dosing schedule in patients with chronic lymphocytic leukemia and acute leukemia. Leuk Lymphoma. 2009;50 (12):1958-63.