Clinical Trials

Last Updated: 4/25/2016

Lymphoma

Marginal Zone Lymphoma, Small Lymphocytic Leukemia

Previously Treated

2015-0811 (MT3724): Extended Treatment Access Study of MT-3724 for Subjects with Relapsed non-Hodgkin’s B-Cell Lymphoma Who Have Completed Phase I/Ib Study MT-3724_NHL_001_US

2014-1072 (ACP-196)  Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with B-cell
Malignancies (Richters transformation)

2014-0504 (MT-3724): Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients with Relapsed non-Hodgkin’s B-Cell Lymphoma

2013-0566 (Ublituximab): Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, and Ibrutinib in Patients with B-cell Malignancies

2013-0261 ( LEN + Obinutuzumab):  Phase I/II study of Lenalidomide and Obinutuzumab (GA101) in Relapsed Indolent Non-Hodgkin’s Lymphoma

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

Follicular Lymphoma

Previously Treated

2015-0811 (MT3724): Extended Treatment Access Study of MT-3724 for Subjects with Relapsed non-Hodgkin’s B-Cell Lymphoma Who Have Completed Phase I/Ib Study MT-3724_NHL_001_US

2015-0663 (BGB-3111):  Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies

2015-0160 (ADCT-301): Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2015-0073 (Daratumumab): Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular
Lymphoma

2015-0038 (Rituximab + Lenalidomide  vs  Rituximab + placebo): Phase 3, Double-blind Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013 Versus Rituximab Plus Placebo in Subjects with Relapsed/Refractory Indolent Lymphoma

2014-1072 (ACP-196 + Pembrolizumab): Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with B-cell Malignancies

2014-0541 (ACP-196 ): An Open-label, Phase 1b Study of ACP-196 in Subjects with Follicular Lymphoma

2014-0539 (ACP-196): Phase II study of rituximab plus pembrolizumab (MK-3475) in subjects with relapsed follicular lymphoma

2014-0504 (M-T3724): Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients with Relapsed non-Hodgkin’s B-Cell Lymphoma

2013-0566 (Ublituximab): Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, and Ibrutinib in Patients with B-cell Malignancies

2013-0261 ( LEN + Obinutuzumab):  Phase I/II study of Lenalidomide and Obinutuzumab (GA101) in Relapsed Indolent Non-Hodgkin’s Lymphoma

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

Diffuse Large B-Cell Lymphoma

Newly Diagnosed 

2015-0147 (RTX + Len + Ibrutinib): Phase II Study of Rituximab, Lenalidomide, and Ibrutinib Combined With Dose Adjusted Chemotherapy For Patients With High Risk Diffuse Large B-Cell Lymphoma

2015-0069 (Ibrutinib + Rituximab): Phase I/II Study of Lenalidomide and Obinutuzumab with CHOP for Diffuse Large B-Cell Lymphoma

2010-0822 (Imaging): FLT-PET/CT vs. FDG-PET/CT for Therapy Monitoring of Diffuse Large B-Cell Lymphoma.

Previously Treated 

2015-0567 (CTL019): Phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

2015-0022: Pilot Project for Creation of the DLBCL Response Prediction Model: Combining Early Interim Functional Imaging, Detection Of A Tumor-Specific Clonotype and Metabolic Profiling of Blood Of In Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma To Predict Response To Standard Immunochemotherapy

2014-0815 (KTE-C19): Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

2014-0705 (IMO8400): Phase 1/2 Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma and MyD88 L265P Mutation

2014-0703 ( KPT-330 + Dexamethasone): Phase 2b Open-label, Randomized Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

2014-0504 (M-T3724): Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients with Relapsed non-Hodgkin’s B-Cell Lymphoma

2013-0566 (Ublituximab): Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, and Ibrutinib in Patients with B-cell Malignancies

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

Hodgkin's Lymphoma

Newly Diagnosed

2011-0104 (SGN-35 + S-AVD): Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients with Untreated Hodgkin Lymphoma

Previously Treated

2015-0160 (ADCT-301): Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

Mantle Cell Lymphoma 

Newly Diagnosed

2014-0559 (Ibrutinib + Rituximab/Hyper-CVAD): Phase II Study of Ibrutinib plus Rituximab with Hyper-CVAD Consolidation in Newly Diagnosed Young Patients with Mantle Cell Lymphoma: A Window Period for Bioimmunotherapy before Chemotherapy

2013-0090 (Ibrutinib + Rituximab): Phase II Study of Ibrutinib Plus Rituximab in Patients with Relapsed/Refractory Mantle Cell Lymphoma or Elderly Patients with Newly Diagnosed MCL

Previously Treated

2015-0811 (MT3724): Extended Treatment Access Study of MT-3724 for Subjects with Relapsed non-Hodgkin’s B-Cell Lymphoma Who Have Completed Phase I/Ib Study MT-3724_NHL_001_US

2015-0663 (BGB-3111): Phase I, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies

2015-0372 (KTE-C19): Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL)

2015-0160 (ADCT-301): Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2015-0073 (Daratumumab): Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma 

2014-0937 (ACP-196):  Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma

2014-0630 (Akt and ERK inhibitor): Phase I/II Study of Oral ONC201 in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma

2014-0504 (M-T3724): Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients with Relapsed non-Hodgkin’s B-Cell Lymphoma

2013-0677 (Ibrutinib):  Phase I Trial of Ibrutinib (BTK inhibitor) in Combination with Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

2013-0259 (Carfilzomib): Phase 2 Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

2013-0090 (Ibrutinib + Rituximab):  Phase II Study of Ibrutinib Plus Rituximab in Patients with Relapsed/Refractory Mantle Cell Lymphoma or Elderly Patients with Newly Diagnosed MCL

2012-1107 (Ibrutinib): Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

2012-0188 (Carfilzomib; Lenalidomide; Rituximab): Phase 1/2 Study of Carfilzomib plus Lenalidomide and Rituximab in the Treatment of relapsed/refractory Mantle Cell Lymphoma.

Burkitt's Lymphoma

Newly Diagnosed

2009-0833 (Rituximab, Dose Adjusted EPOCH): Phase 2 Study of Dose-Adjusted Epoch+/- Rituximab in Adults with Untreated Burkitt's Lymphoma, C-Myc Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma.

Previously Treated 

2015-0811 (MT3724): Extended Treatment Access Study of MT-3724 for Subjects with Relapsed non-Hodgkin’s B-Cell Lymphoma Who Have Completed Phase I/Ib Study MT-3724_NHL_001_US

2015-0160 (ADCT-301): Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2014-0504 (M-T3724):  Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients with Relapsed non-Hodgkin’s B-Cell Lymphoma

 2013-0556 (2014-0324) (Ublituximab): Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, and Ibrutinib in Patients with B-cell Malignancies

2012-0988 (CUDC-907): Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (NKB8237 + Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

T-Cell Lymphoma 

Newly Diagnosed

2015-0555 (Folotyn®): Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with Peripheral T-Cell Lymphoma (PTCL)

2012-0630 (Brentuximab, CHP): Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30-Positive Mature T-Cell lymphomas.  

Previously Treated

2015-0160 (ADCT-301):  Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2015-0130 (RP6530): Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a dual PI3K delta/gamma inhibitor, in Patients with Relapsed or Refractory T-cell Lymphoma

2013-0915 (EBV-Specific T cells):  Phase 2 Open Label Study to Investigate the Efficacy of Autologous EBV-Specific T Cell for the Treatment of Patients with Aggressive Extranodal NK/T Cell Lymphoma (ENKTCL)

2012-0988 (CUDC-907):  Phase 1 Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma

2012-0602 (Romidepsin): Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-cell and T-cell Lymphomas

2012-0183 (Romidepsin + ICE): Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Multiple Myeloma

Amyloidosis

Newly Diagnosed

2015-0554 (NEOD001): A Phase 3, Randomized, Multicenter, Double-Blind,Placebo- Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

Waldenstrom’s

Asymptomatic

2009-0465 ( vaccine ): Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma with DNA Vaccines Encoding Antigen-Chemokine Fusion   

Previously Treated

2014-0728 (ACP-196):  An Open-label, Phase 1b/2 Study of ACP-196 in Subjects with Waldenstrom's Macroglobulinemia

2013-0951 (IMO-8400):  Phase 1/2 Open-Label, Multiple-Dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients with Relapsed or Refractory Waldenstrom’s Macroglobulinemia

Myeloma

Newly Diagnosed 

Symptomatic/Patients Eligible for Transplant 

SWOGS1211 (Elotuzumab +/- Bor, Dex, Len):  Randomized Phase 1/2 Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)

2011-0192 (Lenalidomide, Bortezomib, Dexamethasone, Panobinostat): Phase 1/1b Trial of Efficacy and Safety of the Combination Therapy of Lenalidomide, Bortezomib, Dexamethasone and Panobinostat in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma

2010-0815 (RVD vs. HDT): Randomized Phase 3 Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

Symptomatic/Patients Not Eligible for Transplant 

2015-0019 (Daratumumab): Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs. Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy

Previously Treated

SWOGS1304 (Carfilzomib, Dexamethasone):  Phase 2 Randomized Study Comparing Two Doses of Carfilzomib with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease

2015-0967 (Filanesib):  Open-label, Multicenter Rollover Study to Allow Continued Access to Filanesib (ARRY-520) for Patients with Multiple Myeloma Who Are Currently Receiving Filanesib in Studies Sponsored by Array BioPharma Inc.

2013-0950 (MK-3475 with Len/Dex): Phase 1 Trial of MK-3475 (pembrolizumab) in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma

2012-1159 (SCH 727965, Bortezomib, Dexamethasone): Phase 1 Clinical Trial of a Novel CDK Inhibitor Dinaciclib (SCH 727965) in Combination with Bortezomib and Dexamethasone in Relapsed Multiple Myeloma

2012-0162 (Car/Ben/Dex): A Single Center Phase 1b Study of Carfilzomib, Bendamustine and Dexamethasone in Subjects with Relapsed/Refractory Multiple Myeloma

2011-0336 (Carfilzomib, Dexamethasone, Pomalidomide): A Multi-Center Phase 1/2, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide with Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma.

2011-0144 (ARRY-520):  Phase 1 Study of ARRY-520 (Kinesin Inhibitor) and Carfilzomib in Patients with Relapsed/Refractory Multiple Myeloma

2010-0733 (Panobinostat; Carfilzomib): Phase 1/1b Study of the efficacy and safety of the combination of Panobinostat + Carfilzomib in Patients with Relapsed/Refractory Myeloma

Novel Therapies 

2014-0742 (CWP232291 +/- lenalidomide/dexamethasone): A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety,  Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed or Refractory Myeloma

2013-0018 (Pom/Dex + G-CFS): Phase 1/2 Study of Pomalidomide and Dexamethasone with Growth Factor Support in Patients with Relapsed/Refractory Multiple Myeloma

Myeloma Patients With Renal Impairments

2012-0205 (Pomalidomide + Dexamethasone):  Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety 0f Pomalidomide When Given in Combination with Low Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma and Impaired Renal Function

Maintenance Therapy After Stem Cell Transplant

2014-0729 (Elotuzumab + Lenalidomide):  Phase II Study of the combination of Elotuzumab with Lenalidomide as Maintenance Therapy post Autologous Stem Cell Transplant in Patients with Multiple Myeloma