Open Clinical Trials – Updated October 15, 2018

Immunotherapy AML ALL Non-Hodgkins Lymphoma
Multiple Myeloma Transplant Post Transplant Supportive Care/Other
DiseaseTrial NumberName of TrialDrug & Link to clinicaltrials.gov
Immunotherapy
NSH1099E1910: Phase 3 Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B-ALL in AdultsBlinatumomab NCT02003222
NSH1150Phase 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 TransplantationPembrolizumab NCT02771197
NSH1164A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic MalignanciesXmAB® 14045 NCT02730312
NSH1205A 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
NSH1206A 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 TransplantationBlinatumomab NCT03298412
NSH 1210A 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
AMLNSH 1217(Open in December 2018)A Phase 1/2, Open-Label, Multicentre 2-Part Study to Assess the Safety,Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticle as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia/Myelodysplastic Syndrome Patients Not Eligible for Intensive Induction Therapy.Pending
CAR T-cell: NHLNSH1170A 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 1207A 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 MyelomaNSH1216(Open in December 2018)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
NSH1144A Phase 2, Randomized, Biomarker-Driven, Clinical Study in Patients With Relapsed/Refractory AML With an Exploratory Arm in Patients With Newly Diagnosed High-Risk AMLAlvocidib
NCT02520011
 NSH1150Phase 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 TransplantationPembrolizumab NCT02771197
 NSH1164A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic MalignanciesXmAB®
14045 NCT02730312
 NSH1169A Phase I/II Study of SEL24 in Patients with Acute Myeloid LeukemiaSel24 NCT03008187
 NSH1208A 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
 NSH1209Multicenter, 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
 NSH 1217(Open in December 2018)A Phase 1/2, Open-Label, Multicentre 2-Part Study to Assess the Safety,Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticle as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia/Myelodysplastic Syndrome Patients Not Eligible for Intensive Induction Therapy.Pending
ALL
NSH1099E1910: Phase 3 Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B-ALL in AdultsBlinatumomab
NCT02003222
Non-Hodgkins Lymphoma
 NSH1170A 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
NSH1206A 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 TransplantationBlinatumomab NCT03298412
NSH1207A 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 1210A 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
Multiple Myeloma
NSH1107A 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
NSH1205A 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(Open in December 2018)A Phase 3, Multicenter, Randomized, Open-Label 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 MalignanciesNSH1132A Phase II Trial of Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic MalignanciesFludarabine
Melphalan Cytoxan NCT02581007
 Multiple MyelomaNSH1107A Phase II Trial of High-Dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Upfront Treatment of Multiple MyelomaBendamustine
NCT02416206
AMLNSH1150Phase 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 TransplantationPembrolizumab
NCT02771197
Aplastic AnemiaNSH1158A 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 DonorFludarabine
Cyclophos NCT02828592
Sickle Cell AnemiaNSH1184Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease NCT03263559
NHLNSH 1207A 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
 Post Transplant
AMLNSH1182BMT CTN 1506 Randomized Trial of FLT3 Inhibitor vs Placebo as Maintenance Therapy Post Allogeneic TransplantGilteritinib NCT02997202
NHLNSH1206A 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 TransplantationBlinatumomab NCT03298412
Supportive Care/Other
NSH721NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository NCT00495300 (sample)  NCT01166009 (database)
 NSH943A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other IndicationsNCT01351545
NSH995A 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 1188Non-Treatment research protocol to procure patient-derived blood and tissue samplesNA