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A randomised, open-label phase III trial to evaluate the efficacy and safety of Bexarotene (TargretinTM) capsules combined with PUVA, compared to PUVA treatment alone in patients with Mycosis Fungoide...

Update Il y a 4 ans
Reference: EUCTR2004-003701-24

A randomised, open-label phase III trial to evaluate the efficacy and safety of Bexarotene (TargretinTM) capsules combined with PUVA, compared to PUVA treatment alone in patients with Mycosis Fungoides

Woman and Man

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Extract

To adress whether adding Bexarotene (TargretinTM) to the standard PUVA treatment for patients with stage Ib and IIa Mycosis Fungoides could decrease the cumulative dose of UVA needed to achieve a complete clinical response. The primary objective will therefore be to compare the cumulative dose of UVA required to achieve a CCR in both treatment arms.

Inclusion criteria

  • Patients suffering from histopathologically documented Mycosis Fungoides, clinical stage Ib-IIa

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