Status:
COMPLETED
A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Lymphoma, T-Cell, Cutaneous
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a single-arm (group), open-label (all people know the identity of the intervention), and multicenter study. The study consists of 3 phases including, the screening phase (within 28 days prior ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01486277
Start Date
November 1 2011
End Date
July 1 2016
Last Update
November 3 2016
Active Locations (13)
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1
Pittsburgh, Pennsylvania, United States
2
Nantes, France
3
Paris, France
4
Pessac, France