FRED HUTCHINSON CANCER RESEARCH CENTER 
UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE, DIVISION OF ONCOLOGY 
(08/02/91) 
1. Evaluation of the Use of Recombinant Human G-CSF Stimulated Peripheral Blood Progenitor 
Cell Supplementation in Autologous Bone Marrow Transplantation in Patients with Lymphoid 
Malignancies 
Investigators : W. Bensinger, M.D., Associate Professor of Medicine, UW, Associate Member, FHCRC 
(667-4933); John Nemunaitis, M.D., Associate in Clinical Research, FHCRC; J. Singer, M.D., Professor 
of Medicine, UW, Member, FHCRC (764-2709); CJD. Buckner, M.D., Professor of Medicine, UW, 
Member, FHCRC (667-4324); Associates: F.R. Appelbaum, M.D., Professor of Medicine, UW, 
Member, FHCRC (667-4412); R. Storb, M.D., Professor of Medicine, UW, Member, FHCRC (667- 
4407); Scott Rowley, M.D., Associate Member, FHCRC (667-4416); EJD. Thomas, M.D., Professor of 
Medicine, UW, Member, FHCRC (667-4329); JA.. Hansen, M.D., Professor of Medicine, UW, 
Director, Clinical Research, FHCRC (667-5111), Lloyd Fisher, Ph.D., Professor of Biostatistics, UW, 
Member, FHCRC. 
24-hour phone 206/667-5001. Study Nurse 583-1986. 
2. Introduction 
Delayed neutrophil and platelet recovery after autologous bone marrow transplantation (BMT) 
orrelate with increased infectious and bleeding complications. Despite enhanced neutrophil and 
platelet recovery with rhGM-CSF or rhG-CSF therapy following BMT, the time of pancytopenia 
remains significant. This protocol will evaluate the utility of adding peripheral blood mononuclear cells 
(PBMC) collected following mobilization with rhG-CSF to cryopreserved marrow followed by 
posttransplant G-CSF as a means of accelerating recovery of neutrophils and platelets after 
myeloablative therapy. The major study endpoints will be days of ANC below 100/mm 3 , time to achieve 
an ANC of 500/mm 3 and platelets > 20,000/mm 3 without transfusion. 
3. Background 
Morbidity and mortality of autologous BMT is correlated with the duration and severity of 
myelosuppression. Patients have a substantial risk of bleeding and infection preceding marrow recovery 
(1-5). Possible methods of reducing the duration and severity of myelosuppression include stimulation 
of recovering hematopoietic cells with cytokines such as rhGM-CSF (6,7,8), rhG-CSF (10), rhILl (11), 
rhIL3 (12), and combinations of these (13-16). In Seattle, a double blinded randomized prospective 
trial administering rhGM-CSF or placebo to patients with lymphoid malignancy after autologous BMT 
was recently completed. Results of median values are shown below: 
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Recombinant DNA Research, Volume 16 
