A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, T-Cell, Cutaneous

In brief

The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.

Key facts

Study ID

NCT01486277

Run by

Janssen Research & Development, LLC

People needed

26

Starts

2011-11-01

Expected to finish

2016-07-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa
• Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy)
• Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days
• Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test
• Agrees to protocol defined use of effective contraception
• Adequate laboratory function tests and bone marrow test

You may not qualify if…

• Prior histone-deacetylase inhibitor therapy for CTCL
• Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed)
• Major surgery or radiotherapy within 3 weeks before the start of the study medication
• Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy
• Inadequate gastrointestinal absorption status
• Use of potent inhibitors of CYP3A4/A5
• Positive human immunodeficiency virus

Where it is running

• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Pessac, France
• Study site — Kiel, Germany
• Study site — Minden, Germany
• Study site — Lisbon, Portugal
• Study site — Porto, Portugal
• Study site — Madrid, Spain
• Study site — Málaga, Spain
• Study site — Valencia, Spain
• Study site — London, United Kingdom
• Study site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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