CALGB 10201: A Phase III study of daunorubicin and cytarabine plus or minus G3139 (Genasense, oblimersen sodium, NSC #683428, IND #58842), BCL2 antisense Oligodeoxynucleotide, in previously untreated patients with acute myeloid leukemia (AML) for greater than or equal to 60 years of age.
Principal investigator: Robert J. Gottlieb, MD
Collaborators: G. Thomas O’Conor, MD, Elizabeth Horenkamp, MD, Ashok Beedassy, MD, Shyam Balepur, MD
Sponsor: Cancer and Leukemia Group B
Objective: The primary objective of this study is to determine whether the addition of G3139 to cytarabine/daunorubicin induction chemotherapy and high-dose cytarabine consolidation therapy improves outcome with regard to overall survival, disease-free survival, event-free survival, and complete response rate in previously untreated AML patients who are greater than or equal to 60 years of age.
A Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® PLUS Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naïve to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naïve Patients in Crohn’s Disease) SONIC
Principal Investigator: Dale J. Rosenberg, MD
Collaborators: Richard S. Altman, MD; Carl G. Colton, MD; Daniel C. Connell, MD; Richard J. Elkin, DO; T. Raymond Foley, MD; Ben G. Lazarus, DO; Clifford T. Lomboy, MD; Dale Whitebloom, DO
Sponsor: Centocor, Inc; Centocor B.V.
Objective: Centocor, Inc. (USA) and Centocor B.V. (the Netherlands) are conducting a medical research study designed to investigate the effectiveness of Remicade® (generic name infliximab) and Imuran® (generic name azathioprine) in the treatment of patients with moderate-to-severe Crohn’s disease. The study seeks to determine whether Remicade®, azathioprine, or the combination of both drugs would be the most appropriate treatment for Crohn’s disease patients who have not responded will to certain drugs called 5-ASA drugs (e.g., Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids.
CORAL Study
Principal Investigator: John Briguglio, MD
Collaborators: Edgar Fearnow, MD; Robert Latshaw, MD; Paul Leslie, MD; Leigh Shuman, MD; Robert Gress, MD; Laurence Carroll, MD; Susan Ciampaglia, DO; James Groff, DO; Jeffrey Levine, DO; Jeffrey Martin, MD; Charles Rodenberger, MD
Sponsor: NHLBI (National Heart, Lung and Blood Institute)
Objective: A prospective, multi-center, two-arm, randomized trial. The study is designed to test the hypothesis that medical therapy with stenting of hemodynamically significant (angiographically documented) renal artery stenoses in patients with systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with medical therapy alone.