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