Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

Closures

CTSU/A041202Phase III Intergroup

Permanent Closure to Step 1, Effective 5/16/2016

A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic Leukemia(CLL)
Action CodesER
Study Coordinator(s)Steven E. Coutre, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
Closure Date2015-12-28
S1312Phase I

Temporary Closure, Effective 4/18/2016

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page

Amendments, Revisions, Memoranda

S1207Phase III

Memorandum 1 of 2 - Model Consent Form Corrections Forthcoming

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesNR
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1207Phase III

Memorandum 2 of 2 - Forms Update

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesNR
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1314Phase II

Revision #2

A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Action CodesAC, ER
Study Coordinator(s)Thomas W. Flaig, M.D., Ajjai S. Alva, M.D., Siamak Daneshmand, M.D., Seth P. Lerner, M.D., M. Scott Lucia, M.D., David J. McConkey, Ph.D., Dan Theodorescu, MD, PhD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Other New Items

  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required