| Immunotherapy | AML | ALL | CLL | Non-Hodgkins Lymphoma |
| Multiple Myeloma | Transplant | Post Transplant | Supportive Care/Other |
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| 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 | |
| NSH1224 | A Phase I, Open Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic and Clinical Activity of PF-06863135, A B-Cell Maturation Antigen (BCMA) – CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma (MM) | PF-06863135 NCT03269136 | |
| C-389 | Phase III Study of Daratumumab/rHuPh20 (NSC-810307) Plus Lenalidomide or Lenalidomide as Post Autologous Stem Cell Transplant Maintenance Therapy in Patient with Multiple Myeloma (MM) using Minimal Residual Disease to Direct Therapy Duration (Dramatic Study). | Daratumumab/rHuPh20 (NSC-810307) NCT04071457 | |
| 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 |
| NSH1207 | 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 NCT03575351 | |
| NSH 1230 | A Phase 2 study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients with Aggressive B-cell NHL | JCAR017 NCT03483103 | |
| CART-cell: CLL/Small Lymphocytic Lymphoma | NSH1226 | An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | JCAR017 NCT03331198 |
| 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) | bb2121 NCT03651128 |
| 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 | |
| NSH1164 | A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic Malignancies | XmAB® 14045 NCT02730312 | |
| NSH1208 | 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 | |
| NSH1223 | A Phase 1b Dose-escalation Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome | Plexxikon NCT03787498 | |
| NSH1238 | A Phase Ib study of SEL120 in patients with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome | SEL120NCT04021368 | |
| C374 | A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan administered with chemotherapy versus chemotherapy alone in patients with relapsed/refractory AML | Uproleselan(GMI-1271) NCT03616470 | |
| ALL | |||
| CLL | |||
| CLL | |||
| NSH1226 | An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | JCAR017 NCT03331198 |
|
| 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 | |
| NSH1207 | 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 NCT03575351 | |
| NSH1226 | An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | JCAR017 NCT03331198 |
|
| NSH 1230 | A Phase 2 study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients with Aggressive B-cell NHL | JCAR017 NCT03483103 | |
| Multiple Myeloma | |||
| NSH1216 | A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (rrMM) (KarMMa-3) | CT03651128 | |
| NSH1224 | A Phase I, Open Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic and Clinical Activity of PF-06863135, A B-Cell Maturation Antigen (BCMA) – CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma (MM) | PF-06863135 NCT03269136 | |
| Transplant | |||
| 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 |
| 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 |
| Sickle Cell Anemia | NSH1184 | Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease | NCT03263559 |
| Post Transplant | |||
| GVHD | C369 | BMT CTN 1703 A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/ Tacrolimus/ Mycophenolate Mofetil in Non-Myeloablative/ Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation | NCT0395924 |
| C401 | BMT CTN 1705 – A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha1-Antitrypsin (AAT) Combined with Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-Versus-Host Disease (GVHD) Following allogeneic Hematopoietic Stem Cell Transplant | Alpha1-Antitrypsin (AAT) NCT04167514 | |
| NSH1219 | Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B cell Depleting Therapy with Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease | Rituximab and Ibrutinib NCT Pending |
|
| Multiple Myeloma | C389 | Phase III Study of Daratumumab/rHuPh20 (NSC-810307) Plus Lenalidomide or Lenalidomide as Post Autologous Stem Cell Transplant Maintenance Therapy in Patient with Multiple Myeloma (MM) using Minimal Residual Disease to Direct Therapy Duration (Dramatic Study). | Daratumumab/rHuPh20 (NSC-810307) NCT04071457 |
| 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 | |
| C373 | BMT CTN 1702 Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation and Adult Patients | NCT03904134 | |
| C-393 | BMT CTN 1704 Composite Health Assessment Model for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation (CHARM) and Adult Patients | NCT03992352 | |