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Table 4 New molecular therapeutics and ongoing clinical trials in diffuse large B cell lymphoma

From: New agents and regimens for diffuse large B cell lymphoma

Agent Agent type Combined agent Study Study phase Recruitment status Enrollment (estimated/actual) Indication Results for DLBCLa
Idelalisib PI3K inhibitor NCT03576443 (ILIAD) 2 Recruiting 72 Relapsed GCB DLBCL
Copanlisib PI3Kα/δ inhibitor Nivolumab NCT03484819 2 Recruiting 106 DLBCL failing or ineligible for ASCT
Parsaclisib PI3Kδ inhibitor NCT02998476 (CITADEL-202) 2 Active, not recruiting 60 r/r DLBCL [109]
Parsaclisib PI3Kδ inhibitor R-CHOP NCT04323956 1/1b Not yet recruiting 44 Newly diagnosed, high-risk DLBCL
Parsaclisib PI3Kδ inhibitor Rituximab, bendamustine/ibrutinib NCT03424122 1 Recruiting 81 r/r NHL
BR101801 PI3Kδ and DNA-PK dual inhibitor NCT04018248 1 Not yet recruiting 90 Advanced lymphomas
Umbralisib (TGR-1202) PI3Kδ and CK1 dual inhibitor Ublituximab, bendamustine NCT02793583 (UNITY-NHL) 2/3 Recruiting 900 Previously treated NHL
Everolimus mTORC1 inhibitor Lenalidomide NCT01075321 1/2 Active, not recruiting 58 r/r NHL or HL
Temsirolimus mTORC1 inhibitor Rituximab, DHAP NCT01653067 2 Recruiting 88 r/r DLBCL
Venetoclax BCL2 inhibitor NCT01328626 1 Recruiting 222 r/r CLL and NHL [101]
Venetoclax BCL2 inhibitor Lenalidomide, obinutuzumab NCT02992522 1 Suspended 60 r/r NHL
Venetoclax BCL2 inhibitor Atezolizumab, obinutuzumab NCT03276468 2 Recruiting 138 r/r DLBCL and indolent NHL
Venetoclax BCL2 inhibitor RICE NCT03064867 1/2 Recruiting 64 r/r DLBCL
Venetoclax BCL2 inhibitor DA-EPOCH-R NCT03036904 1 Active, not recruiting 34 DLBCL and HGBCL
Venetoclax BCL2 inhibitor Obinutuzumab, rituximab, polatuzumab vedotin NCT02611323 1 Recruiting 134 r/r DLBCL and follicular lymphoma
Venetoclax BCL2 inhibitor Obinutuzumab NCT02987400 2 Recruiting 21 r/r DLBCL
Entospletinib Spleen tyrosine kinase inhibitor R-CHOP NCT03225924 1/2 Active, not recruiting 25 Newly diagnosed DLBCL aaIPI ≥ 1
Ibrutinib BTK inhibitor ABT-199, rituximab NCT03136497 1 Recruiting 30 r/r DLBCL
Ibrutinib BTK inhibitor ABT-199, prednisone, obinutuzumab, lenalidomide NCT03223610 1b/2 Recruiting 130 CD20 positive B cell lymphoma
Ibrutinib BTK inhibitor Loncastuximab tesirine NCT03684694 1/2 Recruiting 161 Advanced DLBCL, mantle cell lymphoma
Ibrutinib BTK inhibitor Lenalidomide, rituximab NCT02077166 1/2 Active, not recruiting 129 r/r non-GCB DLBCL [119]
Ibrutinib BTK inhibitor R-ICE NCT02955628 2 Recruiting 34 Pre-transplant r/r DLBCL
Ibrutinib BTK inhibitor Buparlisib NCT02756247 1 Active, not recruiting 37 r/r DLBCL, FL, mantle cell lymphoma [95]
ARQ-531 BTK inhibitor NCT03162536 1/2 Recruiting 146 Selected hematologic malignancies
LOXO-305 BTK inhibitor Venetoclax, R-CHOP NCT03740529 1/2 Recruiting 403 CLL/SLL, NHL
DTRMWXHS-12 BTK inhibitor Everolimus, pomalidomide NCT04305444 2 Recruiting 120 r/r CLL, NHL
Acalabrutinib BTK inhibitor NCT02112526 1 Recruiting 21 r/r ABC DLBCL [96]
Acalabrutinib BTK inhibitor RICE NCT03736616 2 Recruiting 47 DLBCL after first-line failure
Acalabrutinib BTK inhibitor DA-EPOCH NCT04002947 2 Recruiting 112 untreated DLBCL
Acalabrutinib BTK inhibitor R-CHOP NCT03571308 1/2 Recruiting 39 untreated DLBCL
Acalabrutinib BTK inhibitor pembrolizumab NCT02362035 1b/2 Active, not recruiting 161 r/r hematologic malignancies [97]
Enzastaurin PKCβ inhibitor R-CHOP NCT03263026 3 Recruiting 235 untreated DGM1-positive DLBCL, IPI ≥ 3
Lenalidomide Immunomodulatory agent NCT04150328 (RE-MIND) 2 Recruiting 500 r/r DLBCL [69]
Lenalidomide Immunomodulatory agent MOR208 NCT02399085 (L-MIND) 2 Active, not recruiting 81 r/r DLBCL, non-transplant eligible [69]
Lenalidomide Immunomodulatory agent R-CHOP NCT00670358 1/2 Recruiting 47 Untreated DLBCL [34]
Lenalidomide Immunomodulatory agent R-CHOP NCT00907348 2 Unknown 49 Elderly untreated DLBCL, IPI ≥ 2 [34]
Lenalidomide Immunomodulatory agent R-CHOP NCT01856192 2 Active, not recruiting 345 Untreated stage II–IV DLBCL
Lenalidomide Immunomodulatory agent R-CHOP NCT02285062 3 Active, not recruiting 570 Untreated ABC DLBCL [36]
Lenalidomide Immunomodulatory agent miniCHOP, subcutaneous rituximab NCT02128061 (SENIOR) 3 active, not recruiting 250 Untreated CD20 + DLBCL, aged over 80 years [37]
Lenalidomide Immunomodulatory agent Rituximab, ibrutinib NCT02636322 2 Active, not recruiting 60 Newly diagnosed non-GCB DLBCL [120]
Itacitinib JAK1 inhibitor Parsaclisib NCT02018861 (CITADEL-101) 1/2 Active, not recruiting 88 r/r B cell malignancies [122]
Itacitinib JAK1 inhibitor Ibrutinib NCT02760485 1/2 Active, not recruiting 33 r/r DLBCL
Ruxolitinib JAK1/2 inhibitor NCT01431209 2 Active, not recruiting 71 r/r NHL failing or ineligible for SCT [123]
Valemetostat EZH1/2 dual inhibitor NCT02732275 1 Recruiting 70 Adults with advanced NHL
Tazemetostat EZH2 inhibitor NCT01897571 1/2 Active, not recruiting 420 NHL and advanced solid tumors [130]
Tazemetostat EZH2 inhibitor R-CHOP NCT02889523 1/2 Suspended 133 Untreated high-risk DLBCL [132]
Tazemetostat EZH2 inhibitor NCT03456726 2 Active, not recruiting 21 r/r NHL, EZH2 mutation
Tazemetostat EZH2 inhibitor NCT02875548 2 Recruiting 300 Patients with antecedent tazemetostat study
Panobinostat HDACi NCT01261247 2 Active, not recruiting 41 r/r NHL
Vorinostat HDACi R-CHOP NCT00972478 1/2 Active, not recruiting 83 Untreated stage 2–4 DLBCL
Chidamide HDACi NCT03201471 2 Recruiting 39 High-risk DLBCL
Romidepsin HDACi 5-Azacitidine NCT01998035 1/2 Active, not recruiting 52 r/r NHL
Selinexor XPO1 inhibitor Venetoclax NCT03955783 1 Suspended 78 r/r high-risk DLBCL, leukemia [143]
Selinexor XPO1 inhibitor R-CHOP NCT03147885 1b/2 Recruiting 44 NHL
Selinexor XPO1 inhibitor RICE NCT02471911 1 Active, not recruiting 23 r/r aggressive B cell lymphoma
  1. NHL non-Hodgkin lymphoma, R-CHOP rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, DLBCL diffuse large B cell lymphoma, r/r relapsed/refractory, EZH enhancer of zeste homolog, CLL chronic lymphocytic leukemia, G-CHOP obinutuzumab, cyclophosphamide, doxorubicin, vincristine, and prednisone, RICE rituximab, ifosfamide, carboplatin, and etoposide, DA-EPOCH-R dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab, HGBCL high-grade B cell lymphoma, HL Hodgkin lymphoma, GCB germinal center B cell like, PI3K phosphatidylinositol-3-kinase, aaIPI age-adjusted international prognosis index, BTK Bruton’s tyrosine kinase inhibitor, SLL small lymphocytic lymphoma, PKCβ protein kinase Cβ, PMBCL primary mediastinal B cell lymphoma, JAK janus kinase, ASCT autologous stem cell transplantation, HDACi histone deacetylase inhibitors
  2. aIf the study results are published, the reference number will be given