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Clinical Trials

Last Updated: 10/2014

Lymphoma

Marginal Zone Lymphoma, Small Lymphocytic Leukemia 

Previously Treated

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

2014-0088  (Ibrutinib + BR or R-CHOP) Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

2014-0324 (Ublituximab): A 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 (Lenalidomid, GA101)A Phase I/II Study of Lenalidomide and GA101 in Relapsed Indolent Non-Hodgkin Lymphoma (Next slot late October)

2012-0740 (hLL1-DOXA): Phase I/II Study of Immunotherapy with hLL1-DOX in Patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). 

2012-0988 (CUDC-907)  Phase I 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

Newly Diagnosed

2013-0897 (Ibrutinib; Rituximab): A Multicenter, Open-Label, Phase 2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab in Previously Untreated Subjects with Follicular Lymphoma.

2011-0805 (Rituximab + Lenalidomide vs. Rituximab + Chemotherapy): A Phase 3 Open-Label Randomized Study to Compare The Efficacy and Safety of Rituximab Plus Lenalidomide Versus Rituximab Plus Chemotherapy Followed by Rituximab In Subjects with Previously Untreated Follicular Lymphoma.

Previously Treated

2014-0324 (Ublituximab): A 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.

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

2014-0088  (Ibrutinib + BR or R-CHOP) Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

2014-0133 (Nivolumab) A Single-Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects with Relapsed or Refractory Follicular Lymphoma (FL)

2013-0261 (Lenalidomid, GA101)A Phase I/II Study of Lenalidomide and GA101 in Relapsed Indolent Non-Hodgkin Lymphoma (Next slot late October)

2012-0602 (Romidepsin)Phase I Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Burkitt's Lymphoma (BL), Double-Hit Lymphomas (DHL), and Other C-Myc Positive B-Cell Lymphomas

2012-0740 (hLL1-DOXA): Phase I/II Study of Immunotherapy with hLL1-DOX in Patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). 

2012-0750 (SGN-CD19A): Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate The Safety and Tolerability Of SGN-CD19A in Patients with Relapsed Or Refractory B-Lineage Non-Hodgkin Lymphoma (Grade 3 Follicular Lymphoma).

2012-0988 (CUDC-907)  Phase I 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

Diffuse Large B-Cell Lymphoma

Newly Diagnosed 

2013-0564 (Brentuximab Vedotin; Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine): A phase 2 study of brentuximab vedotin in combination with standard of care treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [RCHOP]) as front-line therapy in patients with diffuse large B-cell lymphoma (DLBCL).

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

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

Previously Treated 

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

2014-0324 (Ublituximab): A 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, in Patients with B-cell Malignancies (Next slot not available until early November)

2014-0337 (ACP-196):  A Phase 1b, Multicenter, Open-label Study of 2 Dosing Regimens of ACP-196 in Subjects with Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

2013-0425 (Ibrutinib + R-CHOP): A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with R-CHOP in Subjects with Newly Diagnosed Non-GCB-cell Subtype of DLBCL

2012-0221 (MED-551): A Phase 2 Randomized Open-label Study of MEDI-551 in Adults with Relapsed or Refractory DLBCL

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

2012-0750 (SGN-CD19A): Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate The Safety and Tolerability Of SGN-CD19A in Patients with Relapsed Or Refractory B-Lineage Non-Hodgkin Lymphoma. (B-NHL).

2012-0988 (CUDC-907): Phase I 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

2011-1233 (ABT-199): A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination with Bendamustine/Rituximab (BR) in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma

Hodgkin's Lymphoma

Newly Diagnosed

2012-0661 (A+AVD Versus ABVD): A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma

2009-0292 (Rituximab, ABVD): Phase III Study Comparing Rituximab-Supplemented ABVD (R-ABVD) With ABVD Followed by Involved-Field Radiotherapy (ABVD-RT) In LIMITED-Stage ( I-IIA With No Areas of Bulk) Hodgkin's Lymphoma.

Previously Treated 

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

2014-0423 (Nivolumab): Non-Comparative, Two-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in classical Hodgkin Lymphoma (cHL) Subjects after Failure of Autologous Stem Cell Transplant (ASCT)

2013-0973 (Brentuximab Vedotin): Study to Evaluate Biomarkers of Sensitivity and Resistance in Patients with Relapsed/Refractory Hodgkin Lymphoma Who are Treated with Brentuximab Vedotin

2012-0602 (Romidepsin):  Phase I Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Burkitt's Lymphoma (BL), Double-Hit Lymphomas (DHL), and Other C-Myc Positive B-Cell Lymphomas

2012-0988 (CUDC-907): Phase I 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

2010-0065 (Panobinostat, ICE): Phase I Study of Panobinostat Plus ICE Chemotherapy Followed by a Randomized Phase-II Study Of ICE Compared with Panobinostat Plus ICE for Patients With Relapsed and Refractory Classical Hodgkin Lymphoma.

Mantle Cell Lymphoma 

Newly Diagnosed

2013-0056 (Bendamustine, Rituximab, Ibrutinib): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma.

Previously Treated

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

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

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

2012-0602 (Romidepsin):  Phase I Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Burkitt's Lymphoma (BL), Double-Hit Lymphomas (DHL), and Other C-Myc Positive B-Cell Lymphomas

2012-0750 (SGN-CD19A): Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate The Safety and Tolerability Of SGN-CD19A in Patients with Relapsed Or Refractory B-Lineage Non-Hodgkin Lymphoma (B-NHL). 

2012-0988 (CUDC-907): Phase I 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

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

Burkitt's Lymphoma

Newly Diagnosed

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

Previously Treated 

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

2014-0324 (Ublituximab): A 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.

2012-0602 (MLN8237, Romidepsin):  Phase I Trial of MLN8237 plus Romidepsin for Relapsed/Refractory Burkitt's Lymphoma (BL), Double-Hit Lymphomas (DHL), and Other C-Myc Positive B-Cell Lymphomas.

2012-0750 (SGN-CD19A): A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients with Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma.

2012-0988 (CUDC-907): Phase I 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

T-Cell Lymphoma 

Newly Diagnosed

2012-0630 (Brentuximab, CHP): A 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

2014-0018 (Anti-LAG-3): A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacyof Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

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

2012-0602 (Romidepsin)Phase I Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Burkitt's Lymphoma (BL), Double-Hit Lymphomas (DHL), and Other C-Myc Positive B-Cell Lymphomas

2012-0988 (CUDC-907)  Phase I 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

2011-0183 (Carfilzomib): Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma.

Multiple Myeloma

AL Amyloidosis

Newly Diagnosed

2012-0215 (Pomalidomide; Melphalan; Dexamethasone): A Phase I/II Clinical Trial of Pomalidomide with Melphalan and Dexamethasone in Patients with Newly Diagnosed Untreated Systemic AL Amyloidosis

Previously Treated

2012-1142 (Ixazomib; Physician’s Choice): A Phase 3 Randomized, Controlled, Open-Label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician’s Choice of Treatment Administered to Patients with Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Waldenstrom’s

Previously Treated

2013-0951 (IMO-8400): A Phase I/II 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) A Randomized Phase I/II 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 I/Ib Trial of Efficacy and Safety of the Combination Therapy of Lenalidomide, Bortezomib, Dexamethasone and Panobinostat in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma.

Symptomatic/ Patients Not Eligible for Transplant

2013-0569 (Cyclophosphamide; Dexamethasone; Lenalidomide; oprozomib): Phase Ib/2, Multicenter, Open-Label Study of Oprozomib and Dexamethasone in Combination With Lenalidomide or Oral Cyclophosphamide in Patients with Newly Diagnosed Multiple Myeloma.

Previously Treated

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

2014-0307 (DRd vs Rd): Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

2013-0624 (ATRA; Dexamethasone; Revlimid): Phase I/II Study of Lenalidomide (Revlimid), All-trans Retinoic Acid (ATRA) and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma.

2013-0619 (Daratumumab) An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (including a Proteasome Inhibitor and ImiD) or are Double Refractory to a Proteasome Inhibitor and an IMiD

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.

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

2011-0167 (ACY-1215): A Phase I/II, Open-label, Multicenter Study of ACY-1215 (Hystone Deactylase or HDAC Inhibitor) Administered Orally as Monotherapy and in Combination with Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed-Refractory Multiple Myeloma.

2011-0336 (Carfilzomib, Dexamethasone, Pomalidomide): A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide with Dexamethasone in Patients with Relapsed or 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 

2013-0687 (Oprozomib; Pomalidomide; Dexamethasone): Phase 1b/3 Multicenter Study of Oprozomib, Pomalidomide, and Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Myeloma

2012-0107 (Oral LGH447): A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients with Relapsed and/or Refractory Multiple Myeloma.

Myeloma Patients With Renal Impairments

2012-0205 (Pomalidomide + Dexamethasone): A 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

2012-0277 (Lenalidomide, MLN 9708): Phase II Study of the Combination of MLN 9708 with Lenalidomide as Maintenance Therapy post Autologous Stem Cell Transplant in Patients with Multiple Myeloma.


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