Trial & Business Updates:

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S2207Phase II

Permanent Closure of Arm 1 and Discontinuation of Tazemetostat - Effective Date 3/06/2026

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
Action CodesNR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2408Phase III

Temporary Closure - Effective Date 3/16/2026

A Randomized Phase III Blinded Trial of lanreotide for the Prevention of Postoperative Pancreatic Fistula
Action CodesNR
Study Coordinator(s)Robert S. Krouse, M.D., Jonathan Sham, M.D.

Amendments, Revisions, Memoranda

Memorandum 1 of 2 - Cytogenetic Specimen Collection Update

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Memorandum 2 of 2 - IND Safety Report(s) for Venetoclax (ABT-199)

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Memorandum 2 of 2 - IND Safety Report(s) for Venetoclax (ABT-199)

A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
Action CodesNR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.

Memorandum 1 of 2 - Cytogenetic Specimen Collection Update

A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
Action CodesNR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.
S0777Phase III Intergroup

Memorandum - IND Safety Report(s) for Lenalidomide (CC-5013)

A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Action CodesNR
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S1608Phase II Intergroup

Memorandum 1 of 2 - IND Safety Report(s) for Obinutuzumab (Gazyva)

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesNR
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
S1608Phase II Intergroup

Memorandum 2 of 2 - IND Safety Report(s) for Lenalidomide (CC-5013)

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesNR
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY

Memorandum - Note to File has been posted

A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
Action CodesNR
Study Coordinator(s)Meghna Trivedi, M.D., Dawn Hershman, M.D., M.S., Daniel Hertz, PharmD, Ph.D., Stephanie Smith, RN, MSN, OCN
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, SWOG
S1800EPhase II-III

Memorandum - S1800E Upcoming Educational Webinar

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Action CodesNR
Study Coordinator(s)Saiama Waqar, M.D., Tianhong Li, M.D., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 2 of 2 - IND Safety Report(s) for Lenalidomide (CC-5013)

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 CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

Memorandum 1 of 2 - IND Safety Report(s) for Daratumumab

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 CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

Memorandum - IND Safety Report(s) for Sotorasib (AMG 510)

A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
Action CodesNR
Study Coordinator(s)Sukhmani K. Padda, M.D., David Gerber, M.D.
S1905Phase I-II

Memorandum - OBI-3424 Drug Destruction Documentation Needed

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
S1918Phase II-III

Revision #4 - Version Date 3/05/2026

A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
Action CodesIP, AC, ER, NR
Study Coordinator(s)Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1918Phase II-III

Memorandum - S1918 Revision #4 Patient Notification Clarification

A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
Action CodesIP, AC, ER, NR
Study Coordinator(s)Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Memorandum 1 of 2 - IND Safety Report(s) for Obinutuzumab (Gazyva)

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Action CodesNR
Study Coordinator(s)Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D.

Memorandum 2 of 2 - IND Safety Report(s) for Venetoclax (ABT-199)

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Action CodesNR
Study Coordinator(s)Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D.
S1937Phase III

Memorandum - S1937 Investigator and Participant Letters

A Phase III Randomized Trial of Eribulin (NSC #707389) with Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy.
Action CodesNR
Study Coordinator(s)Sarmad Sadeghi, M.D.,Ph.D., Primo N. Lara, Jr., M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S2005Phase II Intergroup

Memorandum 1 of 2 - IND Safety Report(s) for Ibrutinib (PCI-32765)

A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2005Phase II Intergroup

Memorandum 2 of 2 - IND Safety Report(s) for Venetoclax (ABT-199)

A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2114Phase II

Memorandum - IND Safety Report(s) for Mosunetuzumab

A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Memorandum 2 of 2 - IND Safety Report(s) for Tazemetostat

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
Action CodesNR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Memorandum 1 of 2 - IND Safety Report(s) for Lenalidomide (CC-5013)

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
Action CodesNR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 2 of 2 - IND Safety Report(s) for Lenalidomide (CC-5013)

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - IND Safety Report(s) for Daratumumab

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Action CodesNR
S2308Phase III

Memorandum - IND Safety Report(s) for Mosunetuzumab

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Action CodesNR
Study Coordinator(s)Nilanjan Ghosh, MD, PhD
ParticipantsUS INSTITUTIONS ONLY

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