Novel therapeutic agents for cutaneous T-Cell lymphoma

Jain, Salvia; Zain, Jasmine; O’Connor, Owen

doi:10.1186/1756-8722-5-24

Journal of Hematology & Oncology

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			IA=1
					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]
		Phase II			IIA=13
		GPI-04-0001			IIA=13
					IIB=21
			IV		III=23
			IV		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]
Belinostat	Hydrox-amic acid Class I, II, IV HDAC inhibitor	Phase II	IV	29	IV=15	14	7	7	9.1 Months	Clinical activity but not approved		[53]
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		IVA/B=6
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		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]
		Phase II in R/R sALCL⁴	IV	58	Not applicable	86	53	Unknown	Not reached	On-going Phase II trial in CTCL	Neuropathy, nausea, fatigue, neutropenia, diarrhea	[101]
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]
TLR9 agonist vaccine	Enhance host immune response	Phase II	Intra-tumoral injection with radiation	14	IIB=10	35	None	28.5	Not reached	Clinical activity but not approved	Well tolerated	[109]
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]

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ISSN: 1756-8722

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