Trial & Business Updates:

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Priority Lists

Activations

Closures

S1905Phase I-II

Temporary Closure-Effective December 23, 2022

A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN

Amendments, Revisions, Memoranda

Memorandum - Updated Pembrolizumab Investigator’s Brochure

A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
Action CodesER
Study Coordinator(s)John Wrangle, MD, MPH, Hatim Husain, MD

Revision #2 - Version Date 12/7/2022

A Prospective Observational Cohort Study to Assess miRNA371 for Outcome Prediction in Patients with Early Stage Germ Cell Tumors
Action CodesAC, ER
Study Coordinator(s)Craig R. Nichols, M.D., Lucia Nappi, M.D., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCORP COMPONENTS AND SUBCOMPONENTS, CTSU

Revision #4 - Version Date 12/14/2022

A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
Action CodesER
Study Coordinator(s)Veena Shankaran, M.D.
ParticipantsALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Memorandum - Master Forms – Physician Update

A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (eGTB) Intervention to Usual Practice to Increase Evidence-Based Genome Informed Therapy
Action CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

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