I am currently a third year oncology fellow pursuing a clinical research tract in the Transplantation Biology Program of the Clinical Research Division of the Fred Hutchinson Cancer Research Center (FHCRC). I am the principal investigator of anonmyeloablative transplant protocol (FHCRC Protocol 1463) in which hematopoietic stem cells from HLA matched unrelated donors are transfused after a conditioning regimen of fludarabine 30 mg/m2/day x 3 doses and 200 cGy total body irradiation (TBI) followed by novel immunosuppression with cyclosporine (CSP) mycophenolate mofetil (MMF) to treat patients with hematological malignancies. My immediate goals are to obtain essential training in biostatistics and protocol design to improve my ability to design and conduct clinical nonmyeloablative hematopoietic stem cell transplant (HSCT) protocols. My long-term goal is to become an independent academic clinical investigator in order to develop optimal treatment modalities for patients with hematological malignancies. The research career development plan to achieve this goal incorporates didactic courses in Biostatistics and clinical protocol design with established meetings, conferences and presentations within the Transplantation Biology Program and the Clinical Research Division of the FHCRC. The research component of this proposal includes the ongoing FHCRC Protocol 1463, and the development of phase II disease specific protocols using the nonmyeloablative transplant regimen or combining novel treatment modalities such as using the tyrosine kinase inhibitor STI-571 with nonmyeloablative HSCT in the treatment of bcr/abl expressing malignancies. The primary objective of FHCRC Protocol 1463 is to determine whether a nonmyeloablative, less toxic transplant regimen can safely establish hematopoietic allografts from unrelated donors, and whether graft-versus tumor responses will safely eradicate hematological malignancies. The information from this rapidly accruing trial will be used to design phase II disease specific protocols with HLA-matched unrelated donors to explore efficacy and prepare the groundwork for phase I protocols exploring nonmyeloablative transplants from HLA-mismatched related and unrelated donors.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23CA092058-03
Application #
6634076
Study Section
Subcommittee G - Education (NCI)
Program Officer
Gorelic, Lester S
Project Start
2001-07-16
Project End
2006-06-30
Budget Start
2003-03-06
Budget End
2003-12-31
Support Year
3
Fiscal Year
2003
Total Cost
$133,650
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Shustov, Andrei R; Gooley, Theodore A; Sandmaier, Brenda M et al. (2010) Allogeneic haematopoietic cell transplantation after nonmyeloablative conditioning in patients with T-cell and natural killer-cell lymphomas. Br J Haematol 150:170-8
Mielcarek, Marco; Storer, Barry E; Boeckh, Michael et al. (2009) Initial therapy of acute graft-versus-host disease with low-dose prednisone does not compromise patient outcomes. Blood 113:2888-94
Baron, Frédéric; Petersdorf, Effie W; Gooley, Ted et al. (2009) What is the role for donor natural killer cells after nonmyeloablative conditioning? Biol Blood Marrow Transplant 15:580-8
Laport, Ginna G; Sandmaier, Brenda M; Storer, Barry E et al. (2008) Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome and myeloproliferative disorders. Biol Blood Marrow Transplant 14:246-55
Georges, George E; Maris, Michael B; Maloney, David G et al. (2007) Nonmyeloablative unrelated donor hematopoietic cell transplantation to treat patients with poor-risk, relapsed, or refractory multiple myeloma. Biol Blood Marrow Transplant 13:423-32
Baron, Frederic; Sandmaier, Brenda M; Storer, Barry E et al. (2007) Extended mycophenolate mofetil and shortened cyclosporine failed to reduce graft-versus-host disease after unrelated hematopoietic cell transplantation with nonmyeloablative conditioning. Biol Blood Marrow Transplant 13:1041-8
Weiss, A S; Sandmaier, B M; Storer, B et al. (2006) Chronic kidney disease following non-myeloablative hematopoietic cell transplantation. Am J Transplant 6:89-94
Maris, Michael B; Sandmaier, Brenda M; Storer, Barry E et al. (2006) Unrelated donor granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cell transplantation after nonmyeloablative conditioning: the effect of postgrafting mycophenolate mofetil dosing. Biol Blood Marrow Transplant 12:454-65
Baron, Frederic; Storb, Rainer; Storer, Barry E et al. (2006) Factors associated with outcomes in allogeneic hematopoietic cell transplantation with nonmyeloablative conditioning after failed myeloablative hematopoietic cell transplantation. J Clin Oncol 24:4150-7
Baron, F; Maris, M B; Storer, B E et al. (2005) High doses of transplanted CD34+ cells are associated with rapid T-cell engraftment and lessened risk of graft rejection, but not more graft-versus-host disease after nonmyeloablative conditioning and unrelated hematopoietic cell transplantation. Leukemia 19:822-8

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