| Immunotherapy | AML | ALL | Non-Hodgkins Lymphoma |
| Multiple Myeloma | Transplant | Post Transplant | Supportive Care/Other |
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| NSH1099 | E1910: Phase 3 Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B-ALL in Adults | Blinatumomab NCT02003222 | |
| NSH1125 | A Multicenter Phase II, Double-Blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Multiple Myeloma BMT CTN 1302 | Ixazomib NCT02440464 | |
| NSH1150 | Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation | Pembrolizumab NCT02771197 | |
| NSH1164 | A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic Malignancies | XmAB® 14045 NCT02730312 | |
| NSH1205 | A Phase II, Open Label, Randomized, Two-Arm Study to investigate the Efficacy and Safety of Two Doses of the the Antibody Drug Conjugate GSK2857916 in Participants with Relapsed/Refractory Multiple Myeloma who had 3 or more prior lines of treatment, are refractory to a proteasome Inhibitor and an Immunomodulatory Agent and have Failed an Anti-CD38 Antibody (DREAMM2) | GSK2857916 NCT03525678 | |
| NSH1206-Pending IRB Approval | A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects with High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem Cell Transplantation | Blinatumomab NCT03298412 | |
| NSH 1210-Pending IRB Approval | A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Loncastuximab Tesirine NCT03575351 | |
| CAR T-cell: NHL | NSH1170 | A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells, in Relapsed and Refractory (R/R) B-Cell Non-Hodgkin Lymphoma | JCAR017 NCT02631044 |
| NSH 1207-Pending IRB Approval | A global randomized, multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM) | JCAR017 NCT 03575351 | |
| CAR T-cell: Multiple Myeloma | NSH1216 | A Phase 3, Multicenter, Randomized, Open-Lable Study to Compare the Efficacy and Safety of BB2121 versus Daratumumab(DARA) in Combination with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMM-3) | Pending |
| AML | |||
| NSH1144 | A Phase 2, Randomized, Biomarker-Driven, Clinical Study in Patients With Relapsed/Refractory AML With an Exploratory Arm in Patients With Newly Diagnosed High-Risk AML | Alvocidib NCT02520011 |
|
| NSH1150 | Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation | Pembrolizumab NCT02771197 | |
| NSH1164 | A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic Malignancies | XmAB® 14045 NCT02730312 |
|
| NSH1169 | A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia | Sel24 NCT03008187 | |
| NSH1208 Pending IRB Approval | A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients with Hematologic Malignancies | Vyxeos NCT03555955 | |
| NSH1209 Pending IRB Approval | Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients with FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) with Minimal Residual Disease (MRD) | Gilteritinib NCT03070093 | |
| ALL | |||
| NSH1099 | E1910: Phase 3 Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B-ALL in Adults | Blinatumomab NCT02003222 |
|
| Non-Hodgkins Lymphoma | |||
| NSH1170 | A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells, in Relapsed and Refractory (R/R) B-Cell Non-Hodgkin Lymphoma | JCAR017 NCT02631044 | |
| NSH1206-Pending IRB Approval | A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects with High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem Cell Transplantation | Blinatumomab NCT03298412 | |
| NSH1207-Pending IRB approval | A global randomized, multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM) | JCAR017 Pending |
|
| NSH 1210-Pending IRB approval | A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Loncastuximab Tesirine NCT03575351 | |
| C282 | Alliance A051301 – A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype | Ibrutinib NCT02443077 | |
| Multiple Myeloma | |||
| NSH1107 | A Phase II Trial of Nonmyeloablative Haploidentical Peripheral Blood Stem Cell Transplantation Followed by Maintenance Therapy with the Novel Oral Proteasome Inhibitor, MLN9708, in Patients With High-Risk Hematologic Malignancies. | Bendamustine NCT02416206 | |
| NSH1125 | A Multicenter Phase II, Double-Blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Multiple Myeloma BMT CTN 1302 | Ixazomib NCT02440464 | |
| NSH1205 | A Phase II, Open Label, Randomized, Two-Arm Study to investigate the Efficacy and Safety of Two Doses of the the Antibody Drug Conjugate GSK2857916 in Participants with Relapsed/Refractory Multiple Myeloma who had 3 or more prior lines of treatment, are refractory to a proteasome Inhibitor and an Immunomodulatory Agent and have Failed an Anti-CD38 Antibody (DREAMM2) | GSK2857916 NCT03525678 | |
| NSH1216 | "A Phase 3, Multicenter, Randomized, Open-Lable Study to Compare the Efficacy and Safety of BB2121 versus Daratumumab(DARA) in Combination with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMM-3) | Pending | |
| Transplant | |||
| Hematologic Malignancies | NSH1074 | A Phase II Trial of Nonmyeloablative Haploidentical Peripheral Blood Stem Cell Transplantation Followed by Maintenance Therapy with the Novel Oral Proteasome Inhibitor, MLN9708, in Patients With High-Risk Hematologic Malignancies. | MLN9708 NCT02169791 |
| NSH1132 | A Phase II Trial of Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies | Fludarabine Melphalan Cytoxan NCT02581007 |
|
| Multiple Myeloma | NSH1107 | A Phase II Trial of High-Dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Upfront Treatment of Multiple Myeloma | Bendamustine NCT02416206 |
| AML | NSH1150 | Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation | Pembrolizumab NCT02771197 |
| Aplastic Anemia | NSH1158 | A Study of T Cell Replete, HLA-Mismatched Bone Marrow Transplantation With Post-Transplant Cyclophosphamide as a Front-Line Therapy for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor | Fludarabine Cyclophos NCT02828592 |
| Sickle Cell Anemia | NSH1184 | Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease | NCT03263559 |
| NHL | C282 | Alliance A051301 – A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype | Ibrutinib NCT02443077 |
| NSH 1207-Pending IRB approval | A global randomized, multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM) | JCAR017 Pending | |
| Post Transplant | |||
| Multiple Myeloma | NSH1125 | A Multicenter Phase II, Double-Blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Multiple Myeloma BMT CTN 1302 | Ixazomib NCT02440464 |
| AML | NSH1182 | BMT CTN 1506 Randomized Trial of FLT3 Inhibitor vs Placebo as Maintenance Therapy Post Allogeneic Transplant | Gilteritinib NCT02997202 |
| NHL | NSH1206-Pending IRB Approval | A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects with High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem Cell Transplantation | Blinatumomab NCT03298412 |
| Supportive Care/Other | |||
| NSH721 | NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository | NCT00495300 (sample) NCT01166009 (database) | |
| NSH943 | A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications | NCT01351545 | |
| NSH995 | A Multicenter Safety Study of unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients | NCT01656603 | |
| NSH 1188 | Non-Treatment research protocol to procure patient-derived blood and tissue samples | NA | |