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A Phase II Study of Romidepsin in Progressive or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy

[Protocol 07-095]


Full Title :
A PHASE II, MULTICENTER, OPEN-LABEL TRIAL EVALUATING THE ACTIVITY AND TOLERABILITY OF ROMIDEPSIN (DEPSIPEPTIDE, FK228) IN PROGRESSIVE OR RELAPSED PERIPHERAL T-CELL LYMPHOMA FOLLOWING PRIOR SYSTEMIC THERAPY
Purpose :

The goal of this study is to evaluate the safety and effectiveness of an investigational drug called romidepsin (depsipeptide, FK228) in patients with peripheral T-cell lymphoma that has returned despite prior chemotherapy or has not responded to standard therapies. Romidepsin works by blocking the molecular signals that cancer cells need to grow and divide.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of peripheral T-cell lymphoma that has returned despite prior chemotherapy or has not responded to standard therapies.
  • At least 4 weeks must have passed since prior chemotherapy or immunotherapy and 2 weeks since any major surgery and entry into the study.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility, please contact Dr. Steven Horwitz at 212-639-3045.

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