Phase II study of recombinant human granulocyte colony-stimulating factor in children undergoing bone marrow transplantation

Bone Marrow Transplantation

Volumn 18, Issue SUPPL. 2, 1996, Pages 121-128

  Dini, G ^a   Floris, R ^b   Pession, A ^b   Manfredini, L ^a   Dallorso, S ^a   Lanino, E ^a   Garaventa, A ^a   Miano, M ^a   Kotitsa, Z ^a   Rondelli, R ^b  

^a G GASLINI INSTITUTE   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADOLESCENT; ALLOGENIC BONE MARROW TRANSPLANTATION; AUTOLOGOUS BONE MARROW TRANSPLANTATION; CHILD; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ERYTHROCYTE TRANSFUSION; FEMALE; FEVER; HEMATOLOGIC DISEASE; HOSPITALIZATION; HUMAN; HUMAN CELL; INFANT; INFECTION; INTRAVENOUS DRUG ADMINISTRATION; LEUKOCYTE COUNT; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; NEPHROTOXICITY; NEUTROPHIL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RETROSPECTIVE STUDY; SOLID TUMOR; THROMBOCYTE COUNT; THROMBOCYTE TRANSFUSION; TOTAL PARENTERAL NUTRITION;

ADOLESCENT; BONE MARROW TRANSPLANTATION; CHILD; CHILD, PRESCHOOL; FEMALE; FILGRASTIM; GRAFT SURVIVAL; HEMATOLOGIC DISEASES; HUMANS; INFANT; INFUSIONS, INTRAVENOUS; MALE; NEOPLASMS; RECOMBINANT PROTEINS;

EID: 10544223273     PISSN: 02683369     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (27)

1. Anasetti C, Howe C, Petersdorf E W, Martin PJ, Hansen JA: Marrow Transplants from HLA - Matched Unrelated Donors: an NMDP Update and the Seattle Experience. Bone Marrow Transplant 1994 ; 13: 693-695.
2. Nemunaitis J: Rn GM-CSF in Bone Marrow Transplantation in Pediatric Patients. Med Ped Onc 1992; S2: 31-33.
3. Lanino E, Parasole R, Garaventa A, et al. for the Italian Cooperative Group for Neuroblastoma: Treatment of poor-risk neuroblastoma with intensive chemotherapy and recombinant human granulocyte-macrophage colony-stimulating factor. In Cytokines in Hemopoiesis, Oncology and AIDS II. Eds: Freund/Link/Schmidt/Welte. Springer-Verlag, Berlin Heidelberg, 1992; 537-543.
4. Michon J, Bouffet E, Bernard JL, et al.: Administration of recombinant human GM-CSF (rHuGM-CSF) after autologous bone marrow transplantation (ABMT). A study of 21 stage IV neuroblastoma patients undergoing a double intensification regimen. Proceeding of the American Society of Clinical Oncology 1990; 9: 184.
5. Sheridan WP, Morstyn G, Wolf M, et al.: Granulocyte colony-stimulating factor and neutrophil recovery after high-dose chemotherapy and autologous bone marrow transplantation. Lancet 1989; 2: 891-895.
6. Taylor KM, Jagannath S, Spitzer G, et al.: Recombinant human granulocyte colony-stimulating factor hastens granulocyte recovery after high-dose chemotherapy and autologous bone marrow transplantation in Hodgkin's disease. J Clin Oncol 1989; 7: 1791-1799.
7. Peters WP, Kurtzberg I, Atwater: Comparative effects of rHuG-CSF and rHuGM-CSF on hematopoietic reconstitution and granulocyte function following high dose chemotherapy and autologous bone marrow transplantation (abstract). Blood 1988; 72 (suppl 1): 130a.
8. Stahel RA, Muller E, Pichert G, et al.: Dose intensification with autologous marrow support in high risk lymphoma: acceleration of hematopoietic recovery and reduction of days of hospitalization with granulocyte colony stimulating factor (G-CSF) in a randomized open label trial. Am Soc Clin Onco, 1992; 11: 331.
9. Blaise D, Vernant JP, Fiere D, Gluckman E, Reiffers J, Harousseau JL: A randomised, controlled, multicenter trial of recombinant human granulocyte colony stimulating factor (filgrastim) in patients treated by bone marrow transplantation (BMT) with total body irradiation (TBI) for acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). Blood 1992; 80: 248a.
10. Anasetti C, Anderson G, Appelbaum FR, et al.: Phase III study of rhGM-CSF in allogeneic marrow transplantation from unrelated donors. Blood 1993; 82 suppl.1: 454a.
11. Powles R, Smith C, Milan S, et al.: Human recombinant GM-CSF in allogeneic bone-marrow transplantation for leukaemia: double-blind, placebo-controlled trial. Lancet 1990; 11:1417-1420.
12. Masaoka T, Takaku F, Kato S, et al.: Recombinant human granulocyte colony-stimulating factor in allogeneic bone marrow transplantation. Experimental Hematology 1989; 17: 1047-1050.
13. Schriber JR, Chao NJ, Long GD, et al..: Granulocyte colony stimulating factor (G-CSF) following allogeneic bone marrow transplantation. Blood 1993; 82 (suppl 1): 286a.
14. Asano S, Masaoka T, Takoka F, (1991) Beneficial effect of recombinant human glycosylated granulocyte colony-stimulating factor in marrow-transplanted patients: results of multicenter phase II - III studies.Transplant Proc 1991; 23: 1701-1703.
15. Linch DC, Scarffe H, Proctor S, et al.: Randomised vehicle-controlled dose finding study of glycosylated recombinant human granulocyte colony-stimulating factor after bone marrow transplantation. Bone Marrow Transplant 1993; 11: 307-311.
16. Gisselbrecht C., Prentice HG, Bacigalupo A., et al.: Placebo-controlled phase III trial of lenograstim in bone marrow transplantation Lancet 1994; 343: 696-700.
17. Thomas ED, Storb R, Clift RA: Bone marrow transplantation. New Engl J Med 1975; 292: 832-843.
18. European Organization for Research on Treatment of Cancer. Antimicrobial therapy Project group: Prospective randomized comparison of three antibiotic regimens for empirical therapy of suspected bacteremic infection in febrile granulocytopenic patients.Antimicrob Agents Chemother 1986; 2: 263-270.
19. Viscoli C, Castagnola E, Moroni C, et al.: Early complications in children undergoing BMT. Bone Marrow Transplant 1991; 7 (S3): 42-47.
20. Inference based on ranks in the accelerated failure time model. In Kalbfleish JD, Prentice RL. The statistical analysis of failure time data. New York: John Wiley, 1980; pp 143-162.
21. Peto R, Peto J: Asymptotically efficient rank invariant test procedures (with discussion). J Roy Stat Soc 1972; 135: 185.
22. Kaplan EL, Meier P: Non parametric estimation from incomplete observations. J Am Stat Assoc 1988; 53: 457.
23. Bock RD: Multivariate Statistical Methods in Behavioral Research. New York, 1975, Mc Graw-Hill
24. Thomas S, Clark SC, Rappeport JM, Nathan DG, Emerson GG: Deficient T cell granulocyte - macrophage colony stimulating factor production in allogeneic bone marrow transplantation recipients. Transplantation 1990; 49: 703-707.
25. Fabian I, Kletter Y, Bleiberg I, Gadish M, Neparsteck E, Slavin S: Effect of exogenous recombinant human granulocyte and granulocyte-macrophage colony stimulating factor on neutrophil function following allogeneic bone marrow transplantation. Exp Hematol 1991; 19: 868-873.
26. Gulati CG, Bennett CL: Granulocyte-macrophage colony-stimulating-factor (GM-CSF) as adjunct therapy in relapsed Hodgkin's disease. Ann Intern Med 1992; 116: 177-182.
27. Garaventa A, Porta F, Rondelli R: Early death in children after BMT. Bone Marrow Transplant 1992; 10: 419-423