Therefore for this study we have defined as dose limiting toxicity of G-CSF the 
occurrence of a life threatening toxicity not attributable to the preparative regimen in 
any patient, where the occurrence of grade HI or IV transplant related toxicity (see 
Appendix C). If ^ 2 of 3 patients develop grade IQ toxicity or greater this will be 
considered toxic. 
15. Data Analysis 
This study will be a phase II single arm study, designed to accrue 20 patients. 
Pilot data gave a standard deviation of 2.76 for the day of ANC reaching 100 and a standard 
deviation of 6.82 for the day of platelet independence. Using the normal approximation to the 
power of the two-sample t-test for 90% power using a two-sided 0.05 significance test the sample 
sizes required with 22 historical controls were 4 and 18 respectively. For a sample size of four 
the normal approximation is invalid, but with 18 it is reasonable. Thus, 20 patients will be 
studied. 
Toxicity as well as the median time to an ANC > 100, 500 or 1000/mm 3 , day of platelet 
independence, day of discharge, incidence of VOD, and infection will be summarized. 
Abnormal findings from laboratory variables, vital signs, physical exams, and x-rays will be listed 
and summarized. Clinically important side effects noted by the investigator will be summarized 
according to the affected body system. 
16. References 
1. Thomas ED: Marrow transplantation for acute leukemia. Cancer 42: 895-900, 1978. 
2. Meyers JD: Infection in recipients of marrow transplants, Chapter 6. In: Remington JS, Swartz 
MN, (eds.). Current Clinical Topics in Infectious Diseases. New York: McGraw-Hill, p. 261-292, 
1985. 
3. van der Meer JWM, Guiot HFL, van den Broek PJ, van Furth R: Infections in bone marrow 
transplant recipients. Semin Hematol 21: 123-140, 1984. 
4. Buckner CD, Clift RA, Sanders JE, Meyers JD, Counts GW, Farewell VT, Thomas ED, The 
Seattle Marrow Transplant Team: Protective environment for marrow transplant recipients. A 
prospective study. Ann Intern Med 89: 893-901, 1978. 
5. Phillips GL, Herzig RH, Lazarus HM, Fay JW, Wolff SN, Mill WB, Lin H-S, Thomas PRM, 
Glasgow GP, Shina DC, Herzig GP: Treatment of resistant malignant lymphoma with 
cyclophosphamide, total body irradiation, and transplantation of cryopreserved autologous 
marrow. N Engl J Med 310: 1557-1561, 1984. 
6. Brandt SJ, Peters WP, Atwater SK, Kurtzberg J, Borowitz MJ, Jones RB, Shpall EJ, Bast RC Jr, 
Gilbert CJ, Oette DH: Effect of recombinant human granulocyte-macrophage colony-stimulating 
factor on hematopoietic reconstitution after high-dose chemotherapy and autologous bone 
marrow transplantation. N Engl J Med 318: 869-876, 1988. 
7. Nemunaitis J, Singer JW, Buckner CD, Hill R, Storb R, Thomas ED, Appelbaum FR: Use of 
recombinant human granulocyte-macrophage colony-stimulating factor in autologous marrow 
transplantation for lymphoid malignancies. Concise Report. Blood 72: 834-836, 1988. 
8. Nemunaitis J, Singer JW, Buckner CD, Epstein C, Hansen J, Hill R, Storb R, Thomas ED, 
Appelbaum FR. Preliminary analysis of a randomized, placebo-controlled trial of rhGM-CSF in 
autologous bone marrow transplantation (ABMT). ASCO (Abstract), 1990. 
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