Clinical Trials
There are many therapy choices for CTCL (MF/SS) and other cutaneous lymphomas, however none of the currently available therapies have resulted in reliable long-term response or curative results. Also, there are significant toxicities associated with many of the therapies used for patients with advanced disease. Thus, newer therapies that are more effective and safe are greatly in need. In recent years, our cutaneous lymphoma group has been involved in taking a leadership role in the research and development of new therapies in cutaneous lymphoma, whether it isin designing and leading single or multicenter new therapy trials or as part of collaborative translational research at Stanford.
Pilot Study of Brentusimab Vedotin (SGN-35) in Patients with MF with Variable CD30 Expression Level
The purpose of this study is to learn the effects of an investigational medication, SGN 35, on patients with mycosis fungoides. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting. The primary objective is to explore the biologic activity of brentuximab vedotin (SGN-35) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), the most common group of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. More »
A Randomized, Double-blind, Placebo-controlled, Dosage-escalating Phase 1B Study to assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP-141, a Histone Deacetylase Inhibitor, Administered Topically up to 28 Days to Patients with Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
This study will evaluate the efficacy, tolerability and safety of the application of SHP-141, a topical histone deacetylase inhibitor (HDAC-i). This is a Phase I trial, and the first use of this medication in humans. It is for patients with Stage IA-IIA mycosis fungoides. Patients will apply SHP-141 for 4 weeks, and will have skin assessments and skin/blood sampling performed throughout the study period. More »
Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL. More »
Phase I/II Low-dose (12 Gy) TSEBT+ Vorinostat VS Low-dose TSEBT Monotherapy in Mycosis Fungoides
To determine if vorinostat combined with low-dose total skin electron beam therapy (TSEBT) offers superior clinical benefit (efficacy & safety) over low-dose TSEBT alone. More »
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/Cutaneous T-Cell Lymphoma
Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS. More »
Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Relapse after CR on Study KW-0761-001
Primary Objective - To determine the efficacy of additional treatment in subjects who relapse after a complete response to KW 0761 treatment - To describe the adverse event profile in subjects receiving additional courses of KW-0761 Secondary Objectives - To describe the, immunogenicity of KW-0761. More »
