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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 ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-006228-21

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

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Extrait

The primary objective of this trial is to evaluate the activity of romidepsin in patients with progressive or relapsed PTCL following prior systemic therapy. The primary efficacy parameter is the rate of complete response, defined as the proportion of patients with complete response (CR) and unconfirmed complete response [CR(u)] according to the IWC for responses assessment for non-Hodgkin’s lymphomas (NHL).

Critère d'inclusion

  • Progressive or relapsed Peripheral T-Cell Lymphoma (PTCL)

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