Alemtuzumab in Patients with Advanced Mycosis Fungoids: First Interim Report.
Authors: Beltrán-Gárate Brady E. , Huamani-Zavala Julia , Aronés-Valdivia Alfredo , Carrasco-Yalan Antonio A. , de Mendoza Fernando Hurtado , Gómez-Moreno Henry L. 
Published: April 2020

Objectives: Alemtuzumab (Campath®/Mabcampath®, a humanized anti-CD52 monoclonal antibody) has shown to be effective in the treatment of diverse hematological malignancies, including B-cell chronic lymphocytic leukemia and T-cell prolymphocytic leukemia. Mycosis fungoids (MF) is a low grade T-cell cutaneous lymphoma with indolent course and good prognosis while response to chemotherapy is achieved. We started a prospective phase II study in refractory relapse MF cases (advanced disease) treated with i.v. Alemtuzumab (ClinicalTrial.gov Identifier: NCT 00157274)

Methods: From July 2005 to April 2006 a total of eight patients were recruited from 2 centers in Lima-Perú with hystopathological diagnosed of advanced refractory relapse MF. Inclusion criteria include: above 18 years old, ECOG status 0–2, no active infections, no more than 3 previous chemotherapy or radiotherapy, HTLV-1 negative, HIV negative, normal renal or hepatic function and written informed consent. Median age 64 years old (range: 36–72). Five were male. Median number of previous therapies was 2 (range: 2–3). Original treatment scheduled was planed as Alemtuzumab 30 mg i.v. tiw per 12 weeks with a gradually escalated doses during the first week (3, 10, 30 mg). Trimethoprim/sulphamethoxazole and acyclovir prophylaxis was given as regular. Median Alemtuzumab total dose was 283 mg (range: 123–706) over a median of 5 weeks of treatment (range: 3–15). The first four patients (pts.) received the programmed dosification and due toxicity the subsequent 2 pts. received Alemtuzumab 30 mg i.v. tiw for 4 weeks and then 30 mg i.v. weekly and the last 2 recruited pts. received Alemtuzumab 10 mg i.v. tiw for 4 weeks them 10 mg i.v. biw and finally 10 mg i.v. weekly. CMV monitoring with pp65 was performed in the first five pts. and qualitative PCR in the last 3 pts.

Results: Seven patients were evaluated for response, overall response rate (ORR) was 57% (4/7), with two pts. achieving complete remission (CR), two pts. with partial response (PR) and three pts. progressive disease (PD) during treatment. Response duration and follow-up and CMV status is described in table 1. Median Pruritus Analogue Scale was reduced from 4 to 1. Grade 1 neutropenia in one pt. and grade 1 thrombocytopenia in one pt. One patient developed urosepsis caused by E. Coli. No cardiac toxicity was reported. Kaposi’s sarcoma was discovered in a CR pt. (pt 4, table 1)

Conclusions: Alemtuzumab shows promising clinical activity in patients with advanced MF previously treated. Alemtuzumab s.c. as maintenance therapy or in combination with other agents should be explored in advanced MF.

Table 1. Outcomes, follow up and CMV status Alemtuzumab TD (mg) Response Follow-up (m.) CMV status TD=total dose, NE=no evaluable, AD=active disease, m=months, R=Reactivation, F=Fever 1 123 NE AD, 14 m. R with F 2 313 PD Died, 8 m. 3 706 PD AD, 8 m. 4 403 CR Relapse at 6 m. R with F 5 253 CR Relapse at 3 m. R with F 6 493 PR PR, 5 m. 7 123 PR Relapse at 3 m. R no F 8 163 PD AD, 3 m. R no F