Chu P, Deforce D, Pedersen IM, Kim Y, Kitada S, Reed JC, Kipps TJ Latent sensitivity to Fas-mediated apoptosis after CD40 ligation may explain activity of CD154 gene therapy in chronic lymphocytic leukemia. Proc Natl Acad Sci U S A. 2002 Mar 19;99(6):3854-9. Epub 2002 Mar 12.
Clark EA, Ledbetter JA How B and T cells talk to each other. Nature. 1994 Feb 3;367(6462):425-8. Review.
Fox JP, Brandt CD, Wassermann FE, Hall CE, Spigland I, Kogon A, Elveback LR The virus watch program: a continuing surveillance of viral infections in metropolitan New York families. VI. Observations of adenovirus infections: virus excretion patterns, antibody response, efficiency of surveillance, patterns of infections, and relation to illness. Am J Epidemiol. 1969 Jan;89(1):25-50.
Han T, Ezdinli EZ, Shimaoka K, Desai DV Chlorambucil vs. combined chlorambucil-corticosteroid therapy in chronic lymphocytic leukemia. Cancer. 1973 Mar;31(3):502-8.
Hendry L, Bowen A, Matutes E, Swansbury J, Catovsky D Fludarabine, cyclophosphamide and mitoxantrone in relapsed or refractory chronic lymphocytic leukemia and low grade non-Hodgkin's lymphoma. Leuk Lymphoma. 2004 May;45(5):945-50.
Ranheim EA, Cantwell MJ, Kipps TJ Expression of CD27 and its ligand, CD70, on chronic lymphocytic leukemia B cells. Blood. 1995 Jun 15;85(12):3556-65.
Ranheim EA, Kipps TJ Activated T cells induce expression of B7/BB1 on normal or leukemic B cells through a CD40-dependent signal. J Exp Med. 1993 Apr 1;177(4):925-35.
Ranheim EA, Kipps TJ Tumor necrosis factor-alpha facilitates induction of CD80 (B7-1) and CD54 on human B cells by activated T cells: complex regulation by IL-4, IL-10, and CD40L. Cell Immunol. 1995 Apr 1;161(2):226-35.
ROWE WP, HUEBNER RJ, GILMORE LK, PARROTT RH, WARD TG Isolation of a cytopathogenic agent from human adenoids undergoing spontaneous degeneration in tissue culture. Proc Soc Exp Biol Med. 1953 Dec;84(3):570-3.
Sawitsky A, Rai KR, Glidewell O, Silver RT Comparison of daily versus intermittent chlorambucil and prednisone therapy in the treatment of patients with chronic lymphocytic leukemia. Blood. 1977 Dec;50(6):1049-59.
Shanafelt TD, Call TG Current approach to diagnosis and management of chronic lymphocytic leukemia. Mayo Clin Proc. 2004 Mar;79(3):388-98. Review.
Thall PF, Simon R A Bayesian approach to establishing sample size and monitoring criteria for phase II clinical trials. Control Clin Trials. 1994 Dec;15(6):463-81.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
