NTC number | Intervention/treatment | Title | Status | Phase | Number enrolled | Reference / Study results |
---|---|---|---|---|---|---|
NCT00336063 | Drug: Azacitidine Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Vorinostat | Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma | Active, not recruiting | 1 | 18 | Not available |
NCT04220008 | Procedure: Allogeneic hematopoietic stem cell transplantation Drug: Busulfan Drug: Clofarabine Drug: Cyclophosphamide Drug: Gemcitabine Drug: Mycophenolate Mofetil Biological: Rituximab Drug: Tacrolimus Drug: Vorinostat | Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma | Not yet recruiting | 2 | 30 | Not available |
NCT02737046 | Drug: Belinostat Drug: Zidovudine Drug: Interferon-Alfa-2b Drug: Pegylated Interferon-Alfa-2b | Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma | Recruiting | 2 | 20 | Not available |
NCT03770000 | Drug: Tenalisib Drug: Romidepsin | Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma | Recruiting | 1 2 | 42 | [195] 15 pts (CTCL, PTCL; 1 – dose escalation n=9; 2 – dose expansion n=6) No DLT reported in the dose escalation Tenalisib 800 mg BID+ Romidepsin 14 mg/m2 – optimal dose for expansion cohorts AEs: nausea (33%), thrombocytopenia (33%) and fatigue (27%) ≥ Grade 3 AEs: 33% thrombocytopenia (7%), atrial fibrillation (7%), pyrexia (7%) which were (related to romidepsin), anemia (7%) neutropenia (7%), rash (7%) (related to combination) Pts from the dose escalation cohorts (n=9): CR 3, SD 4, PD 2 |
NCT03141203 | Drug: Romidepsin Drug: Carfilzomib | Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients | Active, not recruiting | 1 2 | 50 | Not available |
NCT01796002 | Drug: Romidepsin + CHOP Drug: CHOP | Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma | Active, not recruiting | 3 | 421 | [196] 421 pts (Ro-CHOP, n = 211; CHOP, n = 210) median follow-up of 27.5 mo: Ro-CHOP did not show a statistically significant PFS improvement vs CHOP alone Median PFS for Ro-CHOP vs CHOP: 12.0 mo vs 10.2 mo Median OS for Ro-CHOP vs CHOP was 51.8 mo vs 42.9 mo ORR of Ro-CHOP vs CHOP was 63% vs 60% with CR + CRu rates of 41% vs 37% TEAEs: occurred ≥ 40% in the Ro-CHOP or CHOP arms: anemia (67% vs 38%), nausea (55% vs 31%), thrombocytopenia (52% vs 17%), neutropenia (51% vs 37%), and vomiting (40% vs 10%) Grade 3/4 TEAEs: occurred in ≥ 30% in the Ro-CHOP or CHOP arm: thrombocytopenia (50% vs 10%), neutropenia (49% vs 33%), anemia (47% vs 17%), leukopenia (32% vs 20%) 1 grade 5 TEAEs: Ro-CHOP arm (E. colisepsis), 2 in the CHOP arm (colitis and acute cholecystitis) |
NCT02616965 | Drug: Romidepsin Drug: Brentuximab vedotin | A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma | Recruiting | 1 | 27 | [197] 7 pts No G4 or 5 AEs AEs grade 3: transaminitis, fever AEs: nausea (71%), vomiting (43%), gastroesophageal reflux, constipation, peripheral sensory neuropathy, anorexia, fatigue, thrombophlebitis ORR: 80% (4/5) The median change in mSWAT: a decrease of 59% The median follow-up: 6.1 mo PFS: 12 mo |
NCT02341014 | Drug: Carfilzomib Drug: Romidepsin Drug: Lenalidomide | Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas | Active, not recruiting | 1 2 | 31 | [198] Pts: 16 TCL, 11 BCL The MTD dose for 2: romidepsin 8 mg/m2, lenalidomide 15 mg, carfilzomib 36 mg/m2 ORR for TCL and BCL: 50% Median EFS: 14.5 weeks Median time to best response: 5.7 weeks Median duration of response: 38.7 weeks Grade 3–4 toxicities > 10%: neutropenia, thrombocytopenia AEs: anemia-1, vomiting/diarrhea-1, dyspnea-1, edema-1, febrile neutropenia-1, fever-2, generalized weakness-1, heart failure-1, hypotension-1, infection-2, gastrointestinal bleed-1, and DVT-1 |
NCT01755975 | Drug: Romidepsin Drug: Lenalidomide | Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma | Active, not recruiting | 1 2 | 62 | [199] 21 pts TCL (10 CTCL, 11 PTCL) ORR: 53% (10/19) ORR in PTCL: 50% (5/10, 5 PR) Responses: PTCL-NOS (3), AITL (1), T-PLL (1) ORR in CTCL: 56% (5/9, 2 CR, 3 PR) CR: transformed MF (1), Sézary syndrome (1) Median time to response: 7.3 weeks Median OS not reached Median event-free survival: 15.5 weeks AEs ≥ Grade 3 in 71%: Neutropenia (48%), thrombocytopenia (38%), anemia (33%), electrolyte abnormalities (43%) |
NCT02783625 | Drug: Romidepsin Drug: Bortezomib Drug: duvelisib | Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas | Recruiting | 1 | 115 | [200] (multicenter retrospective cohort study—partial data) |
NCT01908777 | Other: High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin | A 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma | Active, not recruiting | 2 | 47 | [200] (multicenter retrospective cohort study—partial data) |
NCT03547700 | Drug: Romidepsin Drug: Ixazomib | Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) | Active, not recruiting | 1 2 | 11 | Not available |
NCT02223208 | Drug: Ro-CHOEP-21 ( I) Drug: Ro-CHOEP-21 ( II) | Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas | Recruiting | 1 2 | 110 | [201] 21 pts 1 cohort - 3 pts: Ro at 12 mg/ms -no DLTs subsequent 6 cohorts: Ro at 14 mg/ms Nine DLTs were reported in 7 pts Toxicity: 35.2% (95%CI: 17.1%-56.5%) AEs grade 3-4: neutropenia (38%), thrombocytopenia (45%) Severe extra-hematological toxicities: arrhythmia (5%), gastrointestinal (14%) and infections (24%). CR: 12 (57%) PR: 1 (5%) median follow-up: 26 mo 12-mo PFS: 52% (95%CI: 29-71) 12-mo OS: 76% (95%CI: 52-89). |
NCT02232516 | Drug: romidepsin Drug: lenalidomide Other: laboratory biomarker analysis | Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma | Recruiting | 2 | 35 | Not available |
NCT03278782 | Biological: Pembrolizumab Drug: Romidepsin | Study of Pembrolizumab (MK-3475) in Combination With Romidepsin | Active, not recruiting | 1 2 | 31 | [202] Pts: 20 ( I: 6 pts; II: 14 pts) II-ORR: 50% median follow-up: 18 mo CR: 5 pts PR: 2 pts AEs: nusea, vomiting, fatigue |
NCT01947140 | Drug: Pralatrexate Drug: Romidepsin | Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies | Recruiting | 1 2 | 93 | [34] 23 pts All: ORR 57% (13/23), CR 17% (4/23), PR 39% (9/23) TCL: ORR 71% (10/14), CR 40% (4/10), PR 60% (6/10) AEs grade 1-2: nausea (66%), fatigue (52%), anorexia (24%), diarrhea (24%), fever (24%) AEs grade 3-4: anemia (29%), oral mucositis (14%), thrombocytopenia (14%), neutropenia (10%), thrombocytopenia (14%), neutropenia (10%), sepsis (7%), fever (3%), pneumonia (3%) PFS: 3.7 mo (all), 4.4 mo (TCL) DOR: 4.29 mo recommended 2 dose: pralatrexate 25 mg/m2 and romidepsin 12 mg/m2 every 1 week |
NCT04447027 | Drug: Romidepsin Drug: Lenalidomide Drug: 5-azacitidine Drug: Dexamethasone | A 1 Study of Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies | Not yet recruiting | 1 | 30 | Not available |
NCT03161223 | Drug: Durvalumab Drug: Pralatrexate Drug: Romidepsin Drug: 5-Azacitidine | Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma | Recruiting | 1 2 | 148 | Not available |
NCT02181218 | Drug: Romidepsin Drug: Gemcitabine Drug: Oxaliplatin Drug: Dexamethasone Drug: Pegfilgrastim | I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas | Active, not recruiting | 1 | 24 | [200] (multicenter retrospective cohort study – partial data) |
NCT01261247 | Drug: panobinostat Other: laboratory biomarker analysis Genetic: western blotting Genetic: DNA analysis Other: flow cytometry Other: pharmacological study Other: immunohistochemistry staining method | Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma | Active, not recruiting | 2 | 41 | Started: 41 pts Completed: 39 pts Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status: 0.21 Median Overall Survival Time: 14.9 months Median Progression-free Survival Time: 3.1 months Duration of Response:19.7 months All-cause mortality: 0/41 (0.00%) Serious AE: 34/41 (82.93%) Other AEs: 38/41 (92.68%) |
NCT04296786 | Drug: Sintilimab Drug: Chidamide | Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter II Study | Recruiting | 2 | 52 | Not available |
NCT04038411 | Drug: PD-1 Antibody, chidamide, lenalidomide and etoposide | PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma | Recruiting | 4 | 50 | Not available |
NCT03268889 | Drug: Chidamide | Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma) | Unknown | Not Applicable | 39 | Not available |
NCT04490590 | Drug: Chidamide+ Etoposide | A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma | Recruiting | 4 | 30 | Not available |
NCT04040491 | Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine | PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma | Recruiting | 4 | 100 | Not available |
NCT04329130 | Drug: Chidamide, Lenalidomide | Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma | Recruiting | 2 | 44 | Not available |
NCT03321890 | Drug: Chidamide Drug: prednisone Drug: Cyclophosphamide Drug: etoposide Drug: Methotrexate | Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) | Recruiting | 2 | 102 | Not available |
NCT02987244 | Drug: Chidamide Drug: Cyclophosphamide Drug: Epirubicin Drug: Vindesine Drug: EtoposideDrug: Prednisone | Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma | Recruiting | 1 2 | 100 | [203] 82 pts 1b/2 toxicities: leucopenia, anemia, and neutropenia 1b/2: ORR: 68.3%, CR 43.9% 2: ORR: 73.2%, CR 47.8% CR median follow-up: 12.7 mo 1b/2 median PFS: 17.4 mo 1-year PFS: 52.9% 1-year OS: 74.5%. 2 study median PFS: 17.4 mo 1-year PFS: 53.6% 1-year OS: 76.3% |
NCT02879526 | Drug: C-CPT | Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma | Recruiting | 2 | 45 | Not available |
NCT03853044 | Drug: Chidamide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone | Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma | Recruiting | 2 | 23 | Not available |
NCT04480125 | Drug: Azacitidine Drug: Chidamide | Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy | Recruiting | 2 | 28 | Not available |
NCT04414969 | Drug: Anti-PD-1 antibody+Peg-Asparaginase+Chidamide | Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell Lymphoma | Recruiting | 2 | 35 | Not available |
NCT03598959 | Drug: tofacitinib Drug: chidamide | Tofacitinib Combined With Chidamide in R/R ENKTCL | Not yet recruiting | 2 | 20 | Not available |
NCT04511351 | Drug: Chidamide | Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma | Recruiting | Not applicable | 76 | Not available |
NCT04319601 | Drug: Rituximab | Rituximab Combined With Chidamide and Lenalidomide for r/r AITL | Recruiting | Not applicable | 26 | Not available |
NCT03617432 | Drug: Chidamide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Etoposide Drug: Prednisone | Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients | Recruiting | 2 | 114 | Not available |
NCT03820596 | Drug: Sintilimab Drug: Chidamide | Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL | Recruiting | 1 2 | 50 | Not available |
NCT03629873 | Drug: Chidamide | Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects | Recruiting | 2 | 69 | Not available |
NCT04480099 | Drug: CHOP for 6 cycles Drug: CHOP+X for 6 cycles | Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma | Recruiting | 2 | 106 | Not available |
NCT03553238 | Drug: Chidamide Drug: Dexamethasone Drug: vincristine Drug: Cyclophosphamide Drug: Idarubicin Drug: Pegaspargase Drug: Adriamycin Drug: Methotrexate Drug: 6-Mercaptopurine Drug: Etoposide Drug: Cytarabine Procedure: Bone marrow aspiration Procedure: Intrathecal injection Radiation: Radiation therapy Genetic: NGS Procedure: allogeneic hematopoietic stem cell transplantation Diagnostic Test: Flow-MRD Diagnostic Test: FISH Diagnostic Test: Flow immunophenotyping Diagnostic Test: Karyotyping | Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL | Unknown status | 3 4 | 70 | [204] 24 pts ETP-ALL Chidamide: a dose of 10 mg/day AEs: fatigue, nausea, vomit, neutropenia, thrombocytopenia CR: 87% Flow MRD-negative rate: 67% 6 pts with ETP-ALL (25%, 6/24) underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) median follow-up: 20 mo (range, 7-31 mo) estimated 2-year event-free-survival (EFS): 83% |
NCT03925428 | Drug: Entinostat Drug: Molibresib | Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas | withdrawn | 1 | 0 | Not available |
NCT02953301 | Drug: resminostat Drug: Placebo | Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) | Recruiting | 2 | 190 | Not available |
NCT01486277 | Drug: Quisinostat, 12 mg | A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma | Completed | 2 | 26 | [205] 26 pts I – 6 pts 8 mg dose; no CR, PR II – 20 pts 12 mg dose; 1 CR, 3 PR 6/9 pts achieved 50% reduction in mSWAT score at least once, ORR: 21,1% AEs 1-2 grade: nausea (23%), diarrhea (19%), asthenia (12%), thrombocytopenia (12%), hypertension (8%), lethargy (8%), palpitations (8%), pruritus (8%), vomiting (8%) Grade ≥3 AEs: hypertension (4%), lethargy (4%), pyrexia (4%), hyperkalaemia (4%) |
NCT01998035 | Drug: Romidepsin Drug: Oral 5-Azacitidine | Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies | Active, not recruiting | 1 2 | 52 | [206] 31 pts MTD: AZA 300 mg on days 1 to 14 and ROMI 14 mg/m2 on days 8,15 and 22 on a 35-day cycle ORR/CR: 32%/23% (all), 10%/5% (non-T-cell lymphoma), 73%/55% (T-cell lymphoma) AEs: thrombocytopenia, neutropenia, pleural effusion |
NCT02783625 | Drug: Romidepsin Drug: Bortezomib Drug: duvelisib | Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas | Recruiting | 1 | 115 | [200] (multicenter retrospective cohort study – partial data) |
NCT02232516 | Drug: romidepsin Drug: lenalidomide Other: laboratory biomarker analysis | Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma | Recruiting | 2 | 35 | Not available |
NCT02593045 | Biological: IPH4102 | Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL) | Active, not recruiting | 1 | 60 | [82] 44 patients: 35 SS, 8 MF, 1 PTCL-NOS Dose of 750 mg AEs: Grade 1–2: peripheral edema 27%, fatigue 20% Grade 3: Lymphopenia 7% median follow-up: 14,1 mo OR: 16/44 (36,4%) (15/34 SS, 43%) |
NCT03902184 | Biological: IPH4102 Drug: Gemcitabine + Oxaliplatin | IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma | Recruiting | 2 | 250 | Not available |
NCT02927925 | Drug: Daratumumab | A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type | Completed | 2 | 32 | [207] Median follow up: 3.1 mo (n=14) ORR – 35,7% Clinical benefit rate - 42,9% CR – 0% PR – 35,7% SD – 7,1% PD – 57,1 Grade 3-4 AEs: 56% (neutropenia, thrombocytopenia, hypotension) |
NCT04251065 | Drug: Daratumumab | A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin | Not yet recruiting | 2 | 35 | Not available |
NCT02342782 | Biological: Yttrium Y 90 Basiliximab Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Procedure: Autologous Hematopoietic Stem Cell Transplantation Other: Laboratory Biomarker Analysis Other: Pharmacological Study | Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma | Active, not recruiting | 1 | 20 | Not available |
NCT04337593 | Drug: Basiliximab Drug: Pegaspargase | Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL | Not yet recruiting | 2 | 20 | Not available |
NCT02432235 | Drug: ADCT-301 | Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma | completed | 1 | 133 | [208] 39 pts NHL (including CTCL - 8, ATLL - 5, PTCL - 3, AILT -1) TEAEs: 97,4% TEAEs grade ≥3: 74,4% TEAEs leading to discontinuation: 12,8% MTD not reached At doses 60-150 µg/kg ORR: 38,5%, CR: 11,5% TCL pts: ORR 50% (dose ≥60 µg/kg) |
NCT04052997 | Drug: Camidanlumab Tesirine | Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma | Recruiting | 2 | 100 | [209] 47 pts R/R cHL ORR: 80.9% (38/47 pts) CR: with 18 (38.3%) PR: 20 (42.6%) SD: 6 (12.8%) TEAEs: fatigue, nausea, pyrexia, and maculopapular rash, anemia and headache, pruritus, arthralgia, constipation, diarrhea, hypophosphatemia, and rash grade ≥3 TEAEs: 27 (57.4%) pts; the most common (≥5% of pts) hypophosphatemia (6, 12.8%) and gamma-glutamyltransferase increased (3, 6.4%) |
NCT02890368 | Drug: TTI-621 Monotherapy Drug: TTI-621 + PD-1/PD-L1 Inhibitor Drug: TTI-621 + pegylated interferon-α2a Other: TTI-621 + T-Vec Other: TTI-621 + radiation | Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides | Terminated | 1 | 56 | Not available |
NCT02663518 | Drug: TTI-621 Drug: TTI-621 plus Rituximab Drug: TTI-621 plus Nivolumab | A Trial of TTI-621 for Patients With Hematologic Malignancies and Selected Solid Tumors | Recruiting | 1 | 260 | [210] Parts 1−3 (n=214): AEs: infusion-related reaction (IRR, 43%; 3% Gr ≥3), thrombocytopenia (30%; 22% Gr ≥3), chills (21%; 0% Gr ≥3), fatigue (15%; 1% Gr ≥3) Objective responses: - single agent TTI-621: 14/71 (20%) NHL pts: CTCL (n=42, 1 CR, 7 PRs), PTCL (n=22, 2 CRs, 2 PRs) and DLBCL (n=7, 1 CR, 1 PR). Part 4 - 4 dose cohorts (0.5−1.4 mg/kg); 15 pts (MF, n=10; SS n=5) AEs: 11 pts (73%): IRR (n=10), thrombocytopenia (n=3) Gr ≥3 AEs: 4 pts (27%): thrombocytopenia (n=3), IRRs (n=2), exfoliative dermatitis (n=1). 1 PR, 1 skin CR in 6 evaluable pts in the 1 mg/kg cohort 2 responding pts bridged to allogeneic transplantation The mean % change in mSWAT scores -0.4%, -27%, and -37% for 0.5, 0.7 and 1 mg/kg cohorts |
NCT03763149 | Biological: IBI188 | A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas | Active, not recruiting | 1 | 42 | Not available |
NCT02520791 | Biological: Anti-ICOS Monoclonal Antibody MEDI-570 Other: Laboratory Biomarker Analysis Other: Pharmacological Study | Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma | Recruiting | 1 | 38 | [211] Pts: AITL (n= 12), PTCL NOS (n=3), CTCL (n=2) PR: 4, SD: 7 grade 3/4 AEs: decreased CD4+ T-cells, anemia (12%), hypophosphatemia (12%), thrombocytopenia (6%), infusion related reactions (6%). No DLTs reported MTD not established |
NCT00069238 | Biological: Alemtuzumab (Campath) Drug: EPOCH | Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas | Active, not recruiting | 2 | 31 | Overall Number of Participants Analyzed: 31 CR: 17 (54.8%) PR: 7 (22.6%) PD: 2 (6.5%) SD: 1 (3.2%) Not Evaluable: 4 (12.9%) All-cause mortality: 23/31 (74.19%) Serious AE: 23/31 (74.19%) Other AE: 31/31 (100.00%) |
NCT02689453 | Biological: IL-15 plus alemtuzumab | Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) | Active, not recruiting | 1 | 10 | [212] 11 pts: 7 acute ATL, 2 chronic ATL, 2 PTCL-NOS MTD 2μg/kg/day ORR: 45%, CR: 2/11, PR: 3/11 Hematologic AEs: lymphopenia (11), neutropenia (8), anemia (10), and thrombocytopenia (4). non-hematologic AEs: infusion-related reactions, urticaria |
NCT01221571 | Drug: AFM 13 | A Study to Assess AFM13 in Patients With Hodgkin Lymphoma | Completed | 1 | 28 | [126] 28 pts HL doses of 0.01 to 7 mg/kg body weight MTD not reached AEs: mild to moderate PR: 11.5%, SD: 50% Overall disease control rate: 61.5% |
NCT03192202 | Drug: AFM13 | AFM13 in Relapsed/Refractory Cutaneous Lymphomas | Completed | 1 2 | 18 | [213] Pts 9 3 treatment cohorts: I-1.5 mg/kg IV weekly, II-7 mg/kg IV weekly, III-7 mg/kg continuous intravenous infusion over 5 days weekly ORR: 50% Cohort I: 1 CR, 1 PR, 1 SD Cohort II: 3 SD Cohort III: 2 PR AE: infusion related reaction (IRR) |
NCT04074746 | Biological: Anti-CD30/CD16A Monoclonal Antibody AFM13 Drug: Cyclophosphamide Drug: Fludarabine Drug: Fludarabine Phosphate Biological: Genetically Engineered Lymphocyte Therapy | Bispecific Antibody AFM13 Combined With NK Cells for Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas | Recruiting | 1 | 30 | Not available |
NCT04101331 | Drug: AFM13 | II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides | Recruiting | 2 | 145 | Not available |
NCT04162340 | Biological: CD4 CAR T cells | CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies | Recruiting | 1 | 12 | Not available |
NCT04219319 | Drug: Efficacy of LCAR-T2C CAR-T cells | LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma | Recruiting | 1 | 34 | Not available |
NCT03081910 | Genetic: CD5.CAR/28zeta CAR T cells Drug: Fludarabine Drug: Cytoxan | 1 Therapy of Manufactured Autologous T-Cells Expressing a Second Generation Chimeric Antigen Receptor (CAR) for Treatment of T-Cell Malignancies Expressing CD5 Antigen | Recruiting | 1 | 21 | Not available |
NCT03829540 | Biological: CD4CAR | CD4CAR for CD4+ Leukemia and Lymphoma | Recruiting | 1 | 20 | Not available |
NCT03590574 | Biological: AUTO4 | I/II Study Evaluating AUTO4 in Patients With TRBC1 Positive T Cell Lymphoma | Recruiting | 1 2 | 55 | Not available |
NCT01871727 | Drug: E7777 9 mcg/kg | A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma | Recruiting | 3 | 115 | Not available |
NCT02580552 | Drug: Cobomarsen | Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL | Active, not recruiting | 1 | 75 | [214] Pts 24 I – subcutaneous (SC) injection, II - 2-hour intravenous (IV) infusion III – IV rapid bolus injection (≤ 900 mg/dose) MTD not reached AEs: mostly grade 1-2 Improvement in individually treated lesion or total skin diseases: 23/24 95% (CAILS and mSWAT assessments) |
NCT03713320 | Drug: Cobomarsen Drug: Vorinostat | SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides | Active, not recruiting | 2 | 126 | Not available |
NCT03837457 | Drug: Cobomarsen | PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study | Enrolling by invitation | 2 | 60 | Not available |
NCT01476657 | Drug: IPI-145 (duvelisib) | A 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies | Terminated | 1 | 210 | [215] iNHL: ORR: 58% (n = 31), 6 CR relapsed/refractory CLL: 56% (n = 55), 1 CR; peripheral TCL: 50% (n = 16), 3 CR cutaneous TCL, 32% (n = 19). Median time to response: ∼1.8 months. Severe (grade ≥3) AEs: 84% pts neutropenia (32%), alanine transaminase increase (20%), aspartate transaminase increase (15%), anemia and thrombocytopenia (each 14%), diarrhea (11%), and pneumonia (10%) [216] PTCL (n = 16) and CTCL (n = 19), ORR: 50.0% (PTCL) and 31.6% (CTCL) CR: 3 PTCL. grade 3 and 4 AEs: transaminase increases (40% alanine aminotransferase, 17% aspartate aminotransferase), maculopapular rash (17%), neutropenia (17%) |
NCT03711578 | Drug: Tenalisib, | Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL) | Completed | 2 | 20 | Not available |
NCT03707847 | Drug: Crizotinib Drug: Etoposide Capsule Procedure: Auto-HSCT | Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL | Recruiting | 4 | 20 | Not available |
NCT04439266 | Drug: Crizotinib | Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F) | Active, not recruiting | 2 | 35 | Not available |
NCT02034981 | Drug: Crizotinib | 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 | Active, not recruiting | 2 | 246 | Not available |
NCT04439253 | Drug: Crizotinib | Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G) | Active, not recruiting | 2 | 35 | Not available |
NCT03505554 | Drug: Lorlatinib | A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma | Recruiting | 2 | 12 | Not available |
NCT02419287 | Drug: crizotinib | Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas | Unknown status | 2 | 12 | Not available |
NCT01979536 | Drug: Brentuximab Vedotin Drug: Crizotinib Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Ifosfamide Drug: Methotrexate | Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma | Suspended | 2 | 140 | [217] Arm BV of ANHL12P1: addition of brentunixmab vedotin to standard chemotherapy does not cause significantly added toxicity |
NCT03116659 | Drug: Doxycycline Drug: Imiquimod | CTCL Directed Therapy | Recruiting | Early 2 | 8 | Not available |
NCT02341209 | Drug: Doxycycline monohydrate | Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma | Recruiting | 2 | 20 | Not available |