The purpose of the Biostatistics Core is to support the dinical and laboratory-based projects of this program project so that research studies are efficiently designed, conducted, monitored, and analyzed. To ensure that scientifically valid conclusions can be drawn from these experiments, this includes statistical modeling, hypothesis formalization, design of laboratory experiments, clinical trial design, and data analysis. These activities in tum may require development of innovative statistical methods as needed to address new statistical problems as they arise, and accompanying development of appropriate new computer programs to implement these methods. All of these activities are carried out in collaboration with the laboratory and clinical investigators. The specific objectives are:
Aim 1 To provide biostatistical consultation and collaboration in the planning, conduct, analysis and reporting of clinical trials in CML, including phase I trials to determine safe dose combinations, phase II trials to assess therapeutic efficacy, randomized trials to compare competing treatments, and hybrid trials having multiple goals. Trials involving biologic agents or specific types of lymphocytes or stem cells are especially relevant. These statistical designs accommodate multiple patient outcomes, including toxicity, regimen-related death, complete remission (CR), graft-versus-host disease (GVHD) in allogeneic transplantation (allotx) trials, and times to disease remission, progression, onset of CML accelerated phase, blast crisis, and death. Many of the designs accommodate patient heterogeneity by stratification or regression models.that account for patient prognostic characteristics, to help develop individualized treatments when treat-prognosis interactions exist.
Aim 2. To consult and collaborate with researchers evaluating the cellular and molecular basis of response.
Aim 3. T0 develop novel statistical methods for clinical trial design and data analysis as required to address special goals and needs of the projects.
Aim 4. To evaluate prognostic significance of innovative treatments and possible synergistic effects with specific biological and molecular markers. This includes regression, data analysis, and hypothesis formulation.

Public Health Relevance

The statistical methods applied in this program project will ensure that the laboratory experiments and clinical trials are designed reliably and efficiently in order to conserve resources and ensure that valid inferences may be drawn from the resulting data. This also will ensure that the clinical trials meet high ethical standards. In tum, this will enhance the likelihood of achieving the ultimate goal of this research, which is to improve the diagnosis and treatment of CML

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Program Projects (P01)
Project #
Application #
Study Section
Special Emphasis Panel (ZCA1-RPRB-J)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Texas MD Anderson Cancer Center
United States
Zip Code
Kanagal-Shamanna, Rashmi; Jain, Preetesh; Takahashi, Koichi et al. (2017) TP53 mutation does not confer a poor outcome in adult patients with acute lymphoblastic leukemia who are treated with frontline hyper-CVAD-based regimens. Cancer 123:3717-3724
Jain, Preetesh; Burger, Jan A; Khoury, Joseph D (2017) CLL progression after one cycle of FCR: Richter's transformation versus EBV-associated lympho-proliferation. Am J Hematol 92:1113-1114
Zhou, H; Mak, P Y; Mu, H et al. (2017) Combined inhibition of ?-catenin and Bcr-Abl synergistically targets tyrosine kinase inhibitor-resistant blast crisis chronic myeloid leukemia blasts and progenitors in vitro and in vivo. Leukemia 31:2065-2074
Peters, Haley L; Tripathi, Satyendra C; Kerros, Celine et al. (2017) Serine Proteases Enhance Immunogenic Antigen Presentation on Lung Cancer Cells. Cancer Immunol Res 5:319-329
Andersson, B S; Thall, P F; Valdez, B C et al. (2017) Fludarabine with pharmacokinetically guided IV busulfan is superior to fixed-dose delivery in pretransplant conditioning of AML/MDS patients. Bone Marrow Transplant 52:580-587
Issa, Ghayas C; Kantarjian, Hagop M; Gonzalez, Graciela Nogueras et al. (2017) Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment. Blood 130:2084-2091
Jain, Preetesh; Kantarjian, Hagop M; Ghorab, Ahmad et al. (2017) Prognostic factors and survival outcomes in patients with chronic myeloid leukemia in blast phase in the tyrosine kinase inhibitor era: Cohort study of 477 patients. Cancer 123:4391-4402
Raynal, Noël J-M; Da Costa, Elodie M; Lee, Justin T et al. (2017) Repositioning FDA-Approved Drugs in Combination with Epigenetic Drugs to Reprogram Colon Cancer Epigenome. Mol Cancer Ther 16:397-407
Ciurea, Stefan O; Schafer, Jolie R; Bassett, Roland et al. (2017) Phase 1 clinical trial using mbIL21 ex vivo-expanded donor-derived NK cells after haploidentical transplantation. Blood 130:1857-1868
Jain, Preetesh; Kantarjian, Hagop; Jain, Nitin et al. (2017) Clinical characteristics and outcomes of previously untreated patients with adult onset T-acute lymphoblastic leukemia and T-lymphoblastic lymphoma with hyper-CVAD based regimens. Am J Hematol 92:E595-E597

Showing the most recent 10 out of 360 publications