At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed CTCL diagnosis (mycosis fungoides or Sézary syndrome)
- ✓CTCL stages II-A, II-B, III, IV-A, or relapsed stage IB after prior therapy
- ✓Failed skin-directed therapy with at least one prior systemic therapy (interferon, Ontak, chemotherapy, or Targretin)
- ✓Age ≥18 years
- ✕ECOG performance status >1
- ✕No prior systemic therapy for CTCL
- ✕Visceral involvement (stage 4B disease)
- ✕Congenital long QT syndrome, QTc >480 ms, or cardiac arrhythmia requiring anti-arrhythmic medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating romidepsin (depsipeptide, FK228) for Cutaneous T-cell Lymphoma. Completed, enrolled 102 participants across 11 sites in 6 countries.
Detailed Summary
GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
Study Details
Timeline
Interventions
Study patients received romidepsin at a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.