Safe integration of nelarabine into intensive chemotherapy in newly diagnosed T-cell acute lymphoblastic leukemia: Children's Oncology group Study AALL0434

Pediatric Blood and Cancer

Volumn 62, Issue 7, 2015, Pages 1176-1183

  Winter, Stuart S ^a   Dunsmore, Kimberly P ^b   Devidas, Meenakshi ^c   Eisenberg, Nancy ^a   Asselin, Barbara L ^d   Wood, Brent L ^e   Leonard Rn, Marcia S ^f   Murphy, John ^g   Gastier Foster, Julie M ^h,i   Carroll, Andrew J ^j   Heerema, Nyla A ⁱ   Loh, Mignon L ^k   Raetz, Elizabeth A ^l   Winick, Naomi J ^m   Carroll, William L ⁿ   Hunger, Stephen P ^o  

^a UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^b UNIVERSITY OF VIRGINIA CHILDREN S HOSPITAL   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

^d UNIVERSITY OF ROCHESTER   (United States)

^e SEATTLE CHILDREN S HOSPITAL   (United States)

^f UNIVERSITY OF MICHIGAN   (United States)

^g PRINCESS MARGARET HOSPITAL FOR CHILDREN   (Australia)

^h NATIONWIDE CHILDREN S HOSPITAL   (United States)

ⁱ OHIO STATE UNIVERSITY   (United States)

^j UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l UNIVERSITY OF UTAH   (United States)

^m UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

ⁿ NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^o UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

more..

Author keywords

BFM chemotherapy regimen; Nelarabine; T ALL

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARAGINASE MACROGOL; ASPARTATE AMINOTRANSFERASE; LOW MOLECULAR WEIGHT HEPARIN; METHOTREXATE; NELARABINE; ANTINEOPLASTIC AGENT; ARABINONUCLEOSIDE; ASPARAGINASE; MACROGOL DERIVATIVE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CENTRAL NERVOUS SYSTEM DISEASE; CHILD; CONTROLLED STUDY; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MAINTENANCE CHEMOTHERAPY; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MULTIPLE CYCLE TREATMENT; OPPORTUNISTIC INFECTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAGITTAL SINUS THROMBOSIS; SENSORY NEUROPATHY; SIDE EFFECT; T LYMPHOCYTE ACUTE LYMPHOBLASTIC LEUKEMIA; THROMBOCYTOPENIA; CANCER STAGING; FOLLOW UP; INFANT; MORTALITY; PATHOLOGY; PRECURSOR T-CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PRESCHOOL CHILD; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ARABINONUCLEOSIDES; ASPARAGINASE; CHILD; CHILD, PRESCHOOL; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; MALE; METHOTREXATE; NEOPLASM STAGING; POLYETHYLENE GLYCOLS; PRECURSOR T-CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

EID: 84929312499     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.25470     Document Type: Article

References (32)

1. Asselin BL, Devidas M, Wang C, Pullen J, Borowitz MJ, Hutchison R, Lipshultz SE, Camitta BM. Effectiveness of high-dose methotrexate in T-cell lymphoblastic leukemia and advanced-stage lymphoblastic lymphoma: a randomized study by the Children's Oncology Group (POG 9404). Blood 2011; 118: 874-883.
2. Schrappe M, Valsecchi MG, Bartram CR, Schrauder A, Panzer-Grumayer R, Moricke A, Parasole R, Zimmermann M, Dworzak M, Buldini B, Reiter A, Basso G, Klingebiel T, Messina C, Ratei R, Cazzaniga G, Koehler R, Locatelli F, Schafer BW, Arico M. Late MRD response determines relapse risk overall and in subsets of childhood T-cell ALL: Results of the AIEOP-BFM-ALL 2000 study. Blood 2011; 118: 2077-2084.
3. Hunger SP, Lu X, Devidas M, Camitta BM, Gaynon PS, Winick NJ, Reaman GH, Carroll WL. Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: A report from the children's oncology group. J Clinic Oncol 2012; 30: 1663-1669.
4. Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): A randomised controlled trial. Lancet Oncol 2013; 14: 199-209.
5. Pui CH, Evans WE. Treatment of acute lymphoblastic leukemia. N Engl J Med 2006; 354: 166-178.
6. Whitlock JA, Silverman LB, Childhood T-all. It's time to move on. Blood 2011; 118: 828-829.
7. Willemse MJ, Seriu T, Hettinger K, d'Aniello E, Hop WC, Panzer-Grumayer ER, Biondi A, Schrappe M, Kamps WA, Masera G, Gadner H, Riehm H, Bartram CR, van Dongen JJ. Detection of minimal residual disease identifies differences in treatment response between T-ALL and precursor B-ALL. Blood 2002; 99: 4386-4393.
8. Cohen MH, Johnson JR, Massie T, Sridhara R, McGuinn WD, Jr., Abraham S, Booth BP, Goheer MA, Morse D, Chen XH, Chidambaram N, Kenna L, Gobburu JV, Justice R, Pazdur R. Approval summary: Nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma. Clin Cancer Res 2006; 12: 5329-5335.
9. DeAngelo DJ, Yu D, Johnson JL, Coutre SE, Stone RM, Stopeck AT, Gockerman JP, Mitchell BS, Appelbaum FR, Larson RA. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. Blood 2007; 109: 5136-5142.
10. Rodriguez CO, Jr., Stellrecht CM, Gandhi V. Mechanisms for T-cell selective cytotoxicity of arabinosylguanine. Blood 2003; 102: 1842-1848.
11. Raetz EA, Borowitz MJ, Devidas M, Linda SB, Hunger SP, Winick NJ, Camitta BM, Gaynon PS, Carroll WL. Reinduction platform for children with first marrow relapse of acute lymphoblastic Leukemia: A Children's Oncology Group Study[corrected]. J Clin Oncol 2008; 26: 3971-3978.
12. Rivera GK, Zhou Y, Hancock ML, Gajjar A, Rubnitz J, Ribeiro RC, Sandlund JT, Hudson M, Relling M, Evans WE, Pui CH. Bone marrow recurrence after initial intensive treatment for childhood acute lymphoblastic leukemia. Cancer 2005; 103: 368-376.
13. Berg SL, Blaney SM, Devidas M, Lampkin TA, Murgo A, Bernstein M, Billett A, Kurtzberg J, Reaman G, Gaynon P, Whitlock J, Krailo M, Harris MB. Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: A report from the Children's Oncology Group. J Clin Oncol 2005; 23: 3376-3382.
14. Dunsmore KP, Devidas M, Linda SB, Borowitz MJ, Winick N, Hunger SP, Carroll WL, Camitta BM. Pilot Study of Nelarabine in Combination With Intensive Chemotherapy in High-Risk T-Cell Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group. J Clin Oncol : Off J Am Soc Clin Oncol 2012; 30: 2753-2759.
15. Seibel NL, Steinherz PG, Sather HN, Nachman JB, Delaat C, Ettinger LJ, Freyer DR, Mattano LA, Jr., Hastings CA, Rubin CM, Bertolone K, Franklin JL, Heerema NA, Mitchell TL, Pyesmany AF, La MK Edens, Gaynon PS. Early postinduction intensification therapy improves survival for children and adolescents with high-risk acute lymphoblastic leukemia: a report from the Children's Oncology Group. Blood 2008; 111: 2548-2555.
16. Kamps WA, Bokkerink JP, Hahlen K, Hermans J, Riehm H, Gadner H, Schrappe M, Slater R, van den Berg-de Ruiter, Smets E, de Vaan LA, Weening GA, van Weerden RS, van Wering JF, den der ER, Does-van den Berg. Intensive treatment of children with acute lymphoblastic leukemia according to ALL-BFM-86 without cranial radiotherapy: results of Dutch Childhood Leukemia Study Group Protocol ALL-7 (1988 -1991). Blood 1999; 94: 1226-1236.
17. Salzer WL, Devidas M, Carroll WL, Winick N, Pullen J, Hunger SP, Camitta BA. Long-term results of the pediatric oncology group studies for childhood acute lymphoblastic leukemia 1984-2001: A report from the children's oncology group. Leukemia 2010; 24: 355-370.
18. Goldberg JM, Silverman LB, Levy DE, Dalton VK, Gelber RD, Lehmann L, Cohen HJ, Sallan SE, Asselin BL. Childhood T-cell acute lymphoblastic leukemia: the Dana-Farber Cancer Institute acute lymphoblastic leukemia consortium experience. J Clin Oncol 2003; 21: 3616-3622.
19. Nachman JB, Sather HN, Sensel MG, Trigg ME, Cherlow JM, Lukens JN, Wolff L, Uckun FM, Gaynon PS. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. N Engl J Med 1998; 338: 1663-1671.
20. Borowitz MJ, Devidas M, Hunger SP, Bowman WP, Carroll AJ, Carroll WL, Linda S, Martin PL, Pullen DJ, Viswanatha D, Willman CL, Winick N, Camitta BM. Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: A Childre's Oncology Group study. Blood 2008; 111: 5477-5485.
21. Roshal M, Fromm JR, Winter S, Dunsmore K, Wood BL. Immaturity associated antigens are lost during induction for T cell lymphoblastic leukemia: implications for minimal residual disease detection. Cytometry Part B. Clin cytometry 2010; 78: 139-146.
22. Uckun FM, Sensel MG, Sun L, Steinherz PG, Trigg ME, Hareema NA, Sather HN, Reaman GH, Gaynon PS. Biology and treatment of childhood T-Lineage acute lymphoblastic leukemia. Blood 1998; 91: 735-746.
23. Borowitz MJ, Dowell BL, Boyett JM, Pullen DJ, Crist WM, Humphrey GB, Metzgar RS. Clinicopathologic aspects of E-rosette negative T-cell acute lymphocytic leukemia. A Pediatric Oncology Group Study. J Clin Oncolo 1986; 4: 170-177.
24. Reinherz EL, Hussey RE, Schlossman SF. A monoclonal antibody blocking human T cell function. Eur J Immunol 1980; 10: 758-762.
25. Roper M, Crist WM, Metzgar R, Ragab AH, Smith S, Starling K, Pullen J, Leventhal B, Bartolucci AA, Cooper MD. Monoclonal antibody characterization of surface antigens in childhood T- cell lymphoid malignancies. Blood 1983; 61: 830-837.
26. Schorin MA, Blattner S, Gelber RD, Tarbell NJ, Donnelly M, Dalton V, Cohen HJ, Sallan SE. Treatment of childhood acute lymphoblastic leukemia: Results of Dana- Farber Cancer Institute/Children's Hospital Acute Lymphoblastic Leukemia Consortium Protocol 85-01. J Clin Oncol 1994; 12: 740-747.
27. Pui CH, Campana D, Pei D, Bowman WP, Sandlund JT, Kaste SC, Ribeiro RC, Rubnitz JE, Raimondi SC, Onciu M, Coustan-Smith E, Kun LE, Jeha S, Cheng C, Howard SC, Simmons V, Bayles A, Metzger ML, Boyett JM, Leung W. Treating childhood acute lymphoblastic leukemia without cranial irradiation. The New England journal of medicine 2009; 360: 2730-2741.
28. Reiter A, Schrappe M, Ludwig WD, Hiddemann W, Sauter S, Henze G, Zimmermann M, Lampert F, Havers W, Niethammer D, et al. Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86. Blood 1994; 84: 3122-3133.
29. Buie LW, Epstein SS, Lindley CM. Nelarabine: A novel purine antimetabolite antineoplastic agent. Clin Ther 2007; 29: 1887-1899.
30. Kisor DF, Plunkett W, Kurtzberg J, Mitchell B, Hodge JP, Ernst T, Keating MJ, Gandhi V. Pharmacokinetics of nelarabine and 9-beta-D-arabinofuranosyl guanine in pediatric and adult patients during a phase I study of nelarabine for the treatment of refractory hematologic malignancies. J Clin Oncol 2000; 18: 995-1003.
31. CDC Definitions of Nosocomial Infections: Association for Practioners in Infection Control and Epidemiology, Inc. Infection Control and Applied Epidemiology: Principles and Practice. St. Louis Mosby 1996. p A1-A20.
32. van der Velden VH, Jacobs DC, Wijkhuijs AJ, Comans-Bitter WM, Willemse MJ, Hahlen K, Kamps WA, van Wering ER, van Dongen JJ. Minimal residual disease levels in bone marrow and peripheral blood are comparable in children with T cell acute lymphoblastic leukemia (ALL), but not in precursor-B-ALL. Leukemia 2002; 16: 1432-1436.