Table IV.
List of studies on chlormethine (CL) gel
| Study | Year | Type of study | Patients N | Efficacy | Dermatitis, % |
|---|---|---|---|---|---|
| 201 | 2013 | RCT | 260 | RR 59% (CAILS) 46.9% (mSWAT) Time to response demonstrated superiority of CLgel to ointment (p<0.012) |
15–20 |
| PROVE | Ongoing | Prospective observational study of real world | 301/298 during MG | 1/3 (33.3%) of participants with Stage IA–IB MF-CTCL CR at month 12 2/3 (66.6%) CR at month 18 CLgel was well tolerated with responders reporting significantly improved HR-QoL compared with non-responders |
12.8 |
| MIDAS | Ongoing | Non-randomized open-label split-face 2-arm study | 78 | CAILS assessment showed similar clinical responses to CL gel with or without concomitant corticosteroid treatment over 6 months | 33.3 |
| Current study | 2019 | Non-randomized open-label | 23 | OR: 15/23 (65.22%) NRCR: 2/15 (13.33%) CR: 5/15 (33.33%) PR: 8/15 (53.33%) at month 9 |
43.47 |
mSWAT: modified Severity Weighted Assessment score; CR: complete response; NRCR: near complete response; OR: overall response; PR: partial response; SD: stable disease; HR-QoL: health-related quality of life; MF-CTCL: mycosis fungoides cutaneous T cell lymphoma; MIDAS: mechlorethamine induced dermatitis assessment study (9); PROVE: the prove study (8); RCT: randomised control trial ; CAILS: composite assessment of index lesion severity; MG: monitoring.