A single agent Phase II study of depsipeptide (FK228) in the treatment of Cutaneous T-cell lymphoma

Update Il y a 4 ans
Reference: EUCTR2004-001012-32

Woman and Man

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Extract

To confirm the efficacy of FK228, depsipeptide, as reported in the Phase I and early Phase II studies, in patients with CTCL who are no longer controlled on skin-directed therapy and who have had at least one prior systemic therapy. The rate of objective disease control, as determined by Objective Primary Disease Response Evaluation Criteria (OPDREC) will be used as the primary endpoint to assess efficacy.


Inclusion criteria

  • Cutaneous T-cell lymphoma (CTCL) (Peripheral T-cell lymphoma unspecified NOS)