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

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