Priority Lists
Protocol Posting of
Activations
Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Study Coordinator(s) | James Yu, M.D. |
Partial Re-Activation (Cohort 2) - Effective 9/23/19
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
Action Codes | IP, AC, ER |
Study Coordinator(s) | Anjali S. Advani, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Temporary Closure - Effective 10/4/19
A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action Codes | AC, ER, NR |
Study Coordinator(s) | Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D. |
Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Temporary Closure of Cohorts #40 and #46- Effective 10/3/2019
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | NR |
Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Amendments, Revisions, Memoranda
Revision #1 - Version Date 8/19/19
A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action Codes | NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum – Master Forms Update
A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action Codes | NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
Action Codes | ER |
Study Coordinator(s) | Jason A. Zell, D.O. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Revision #4 - Version Date 7/15/19
A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Action Codes | 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 |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #13- Version Date 8/19/19
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
Action Codes | IP, AC, ER |
Study Coordinator(s) | Anjali S. Advani, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Ipilimumab Safety Report (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - Nivolumab Safety Report (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Ipilimumab Safety Report
A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High-Risk Resected Melanoma
Action Codes | ER |
Study Coordinator(s) | Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #10 - Version Date 9/13/19
A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
Action Codes | ER |
Study Coordinator(s) | Scott Ramsey, M.D., Dawn Hershman, M.D., M.S., Gary Lyman, M.D., Sean Sullivan, Ph.D. |
Participants | Limited: Institutions Listed on the Title Page |
Revision #4 – Version Date 08/14/19
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases
Action Codes | ER |
Study Coordinator(s) | Eve Rodler, M.D., Priyanka Sharma, M.D., Julie R. Gralow, M.D. |
Participants | CTSU |
Memorandum 1 of 2 - Spanish Consent, Consent Addendum, Certificate of Translation (Date 07/30/19)
A Randomized Phase III Trial to Evaluate Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/=1 CM Residual Invasive Cancer or Positive Lymph Nodes (>ypN+) After Neoadjuvant Chemotherapy.
Action Codes | ER |
Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - Updated BAHO Quality of Life Questionnaires
A Randomized Phase III Trial to Evaluate Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/=1 CM Residual Invasive Cancer or Positive Lymph Nodes (>ypN+) After Neoadjuvant Chemotherapy.
Action Codes | ER |
Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Cabozantinib Safety Report
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)
Action Codes | ER |
Study Coordinator(s) | Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #1 - Version Date 8/30/19
A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action Codes | AC, ER, NR |
Study Coordinator(s) | Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D. |
Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Revision #4 - Version Date 7/22/19
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
Action Codes | IP, ER |
Study Coordinator(s) | Robert S. Svatek, M.D., Ajjai S. Alva, M.D., Seth P. Lerner, M.D., Joshua Meeks, M.D., Scott Gilbert, M.D., Rick Bangs |
Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum 1 of 2- Ipilimumab Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | NR |
Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 2 of 2- Nivolumab Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | NR |
Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Nivolumab Safety Report
A Randomized Phase II/III Trial of "Novel Therapeutics" versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
Action Codes | ER |
Study Coordinator(s) | Laura Michaelis, MD, Roland Walter, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Ipilimumab Safety Report
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
Action Codes | ER |
Study Coordinator(s) | Ari VanderWalde, M.D., Antoni Ribas, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU |
Memorandum 2 of 2 - Nivolumab Safety Report
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
Action Codes | ER |
Study Coordinator(s) | Ari VanderWalde, M.D., Antoni Ribas, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU |
Memorandum - Update STAI-S Version 1.1 and Cover Sheet for Patient -Completed Questionnaires
Randomized trial comparing overall survival of patients monitored with serum tumor marker directed disease monitoring (STMDDM) versus usual care in patients with metastatic hormone receptor positive breast cancer
Action Codes | NR |
Study Coordinator(s) | Melissa Accordino, M.D. |
Participants | ALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 3 - Drug order process and shipment details
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | NR |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 3 - Physician Registration Form
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | NR |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 3 of 3 - Daratumumb guidance document / video
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | NR |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Nivolumab Safety Report
A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Action Codes | ER |
Study Coordinator(s) | Alex Herrera, M.D., Jonathan W. Friedberg, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
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