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A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

Phase 2
18 Years
Open (Enrolling)
Cutaneous T-cell Lymphoma; Histone Deacetylase Inhibitor; Lymphoma; Oncology

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Trial Information

A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

All patients entered in the study will receive treatment with JNJ-26481585. This study will
have three phases: a Screening Phase (from signing of informed consent until immediately
before dosing), a Treatment Phase (from the first dose of study drug until the
End-of-Treatment Visit), and a Follow-up Phase (after the End-of-Treatment Visit until
clinical cut-off). Clinical cut-off is defined as when the last patient in the study has
been assessed with progressive disease or died, or 6 months after the last patient is
randomly assigned to treatment, whichever occurs first. However, if any patients are still
receiving study treatment at the time of clinical cut-off, these patients will enter a
Long-term Extension Phase and continue to receive study treatment until a reason for
discontinuation is met (ie, disease progression, toxicity, availability of other effective
drugs that the patient may receive, or treating physician advice). The Long-term Extension
Phase will continue for a maximum of 2 years beyond the clinical cut-off for primary
analysis. Patients will be closely monitored for adverse events (AEs), laboratory
abnormalities, and clinical response, according to the scheduled assessments. The patients
will receive JNJ-26481585, 12 mg, orally on Days 1, 3, and 5 of each week in a 21-day
treatment cycle. JNJ-26481585 is to be taken with approximately 200 mL of water once a day.
Treatment will continue until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2

- Histopathologically-confirmed CTCL, either mycosis fungoides or Sezary syndrome Stage

- Relapsed or refractory (unresponsive) disease following at least 1 prior systemic
therapy for CTCL. Psoralen and long-wave ultraviolet (PUVA) radiation is considered
skin-directed therapy and not systemic therapy

- Patients must have recovered from toxicity related to prior systemic therapy after at
least a 2-week wash-out period)

- 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 in
the longest diameter

Exclusion Criteria:

- Prior histone-deacetylase inhibitor therapy for CTCL

- Concurrent systemic corticosteroid dose > 10 mg/day of prednisone or equivalent
(stable use of <=10 mg/day of prednisone for 1 month or more before study entry is

- Major surgery or radiotherapy within 3 weeks before study drug administration (focal
radiotherapy for local disease control is allowed. Patients must have recovered from
prior radiotherapy or surgery-related toxicity)

- Other malignancy within past 5 years, except for protocol-specified exceptions

- 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

- Any other heart abnormality that, in the opinion of the investigator, medical
monitor, or consultant cardiologist, may place the patient at an unacceptably
increased risk with study drug

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine overall cutaneous response (RR) rate, based on modified Severity Weighted Assessment Tool (mSWAT) criteria

Outcome Description:

The RR is defined as the proportion of evaluable subjects who achieve a CR (complete disappearance of all cutaneous disease) or PR (≥ 50% reduction in mSWAT score compared with baseline). mSWAT score : The skin tumor burden will be assessed according to mSWAT evaluation. The investigator will determine the percentage of total body surface area (TBSA) affected in 12 body regions, using the subject's palm and fingers representing 1% of TBSA.

Outcome Time Frame:

Up to two years

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

November 2014

Related Keywords:

  • Cutaneous T-cell Lymphoma; Histone Deacetylase Inhibitor; Lymphoma; Oncology
  • Cutaneous T-cell lymphoma; Histone Deacetylase Inhibitor; Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



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