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Table 1 Summary of Major Clinical Trials of Novel Drugs in CTCL

From: Novel therapeutic agents for cutaneous T-Cell lymphoma

Agent Target Type of Study Dose No of Patients Stage of Patients ORR [CR +PR] (%) CR (%) PR (%) Median DoR1 Status in CTCL Major side- effects Reference
Vorinostat Hydrox-amic acid Class I, II, IV HDAC inhibitor Phase II 400mg oral/d 74 IB=11 29.7 1.35 28.35 Not reached Approved for R/R2 CTCL Diarrhea fatigue, nausea, anorexia, changes in taste, thrombocyto-penia, eight decrease [35]
IIA=2
IIB=19
III=20
IVA=18
IVB=4
Romi- depsin Cyclic peptide Class I, II, IV HDAC inhibitor Phase II 14 mg/m2 on days 1, 8, 15 every 28days 71 IA=1 33 7 26 13.7 months Approved for R/R2 CTCL Fatigue, nausea, thrombocyto-penia, anemia, Hypocal-cemia [40]
NCI-1312
IB=6
IV IIA=2
IIB=15
IIIA=3
IIIB=3
IVA=28
IVB=13
   Phase II 14 mg/m2 on days 1, 8, 15 every 28days 96 IB=15 34 6 28 15 months Approved for R/R2 CTCL Nausea, asthenia, vomiting, anorexia [41]
IIA=13
GPI-04-0001
IIB=21
IV III=23
IVA=24
Belinostat Hydrox-amic acid Class I, II, IV HDAC inhibitor Phase II 1000 mg/m2 on days, 1-5 every 3weeks 29 IV=15 14 7 7 9.1 Months Clinical activity but not approved Neutro-penia, thrombocyto-penia pruritis, rash, edema, adynamic ileus [53]
IV
Panobio- stat Hydrox-amic acid Class I, II, IV HDAC inhibitor Phase II 20mg orally on days 1,3,5 every 28 days 95 ≥ IIB=68 15.78 2 13.78 Not reached Clinical activity but not approved Diarrhea, thrombocyto-penia, nausea, pruritus, fatigue, asthenia [55]
Prala- trexate RFC-1 Phase I Dose finding study 29 at optimal dose of 15 mg/m2 weekly x 3 every 4 weeks IV Data not available 43 Un-known Un-known Not reached Clinical activity and acceptable toxicity at MTD. Fatigue, nausea, mucositis, edema, epistaxis [65]
Bortez- omib Various Phase II 1.3 mg/m2 on days 1,4, 8 and 11 every 21 days 10 IIIA=1 70 10 60 9 months Clinical activity but not approved Neutropenia, thrombocyto-penia, sensory neuropathy [76]
IIIB=3
IVA/B=6
IV
Foro- desine Inhibits purine nucleoside phophoryla-se Phase I Dose finding study 40–320 mg/m2 oral daily 9 ≥ III=8 55 22 33 Not reached On-going Phase II trial in CTCL Nausea, fatigue, dyspnea, edema, urinary casts [81]
Alemtu- zumab Mono-clonal anti-body against CD52 Phase II Escalating dose up to 30 mg thrice/week 22 IIA=1 52 21.4 14.2 Not reached Approved for use in CTCL Fever, rigors, nausea, fatigue, hypotension [85]
IIB=2
IIIA=6
IIIB=4
IVA=7
IV
IVB=2
SGN-35 Anti-CD30 combined with cytotoxic agent auri-statin Phase II in R/R2 Hodgkin lymphoma after ASCT3 1.8 mg/kg every 3 weeks IV 102 Not applicable 75 34 Unknown Not reached On-going Phase II trial in CTCL Neuropathy, nausea, fatigue, neutropenia, diarrhea [100]
   Phase II in R/R sALCL4 1.8 mg/kg every 3 weeks 58 Not applicable 86 53 Unknown Not reached On-going Phase II trial in CTCL Neuropathy, nausea, fatigue, neutropenia, diarrhea [101]
IV
TLR9 agonist vaccine Enhance host immune response Phase II Intra-tumoral injection with radiation 14 IB=5 35 None 28.5 Not reached Clinical activity but not approved Well tolerated [109]
IIB=10
Lena- lidomide IMiD Phase II 25 mg orally daily for 21 days followed by 1 week of rest 15 Not available 30 None 30 Not reached On-going larger Phase II trial in CTCL anemia, fatigue malaise, skin burning, pruritus, lower leg edema, initial flare of disease [110]