Phase I Dose-finding and Preliminary Efficacy Study of the Istodax® in Combination With Doxil® for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma

Summary

This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best response, 8 cycles, disease progression or intolerability whichever comes first. Importantly, doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed until disease progression or death whichever comes first.

Timeline

Start

2014-03-04

Primary completion

2018-07-13

Completion

2020-04-11

Drugs

Indications