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Table 2 Ongoing clinical trials of targeted therapies in T cell lymphomas

From: Novel targeted therapies of T cell lymphomas

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
  1. Pts—patients; TCL—T cell lymphoma; BCL—B cell lymphoma, CTCL—cutaneous T cell lymphoma; ATLL—adult T cell leukemia/lymphoma, PTCL—peripheral T cell lymphoma, AILT—angioimmunoblastic T cell lymphoma, ATL—adult T cell leukemiia, PTCL—NOS-peripheral T cell lymphoma not otherwise specified, MTD—maximum tolerated dose; ORR—overall response rate; CR—complete response; CRu—CR unconfirmed; PR—partial response; AE—adverse events; SD—stable disease; PD—progressive disease; TEAES—Treatment Emergent Adverse Events; mo—months