Methods |
This is a multicentre, open‐label, randomised, phase I/II study evaluating the safety and efficacy of low‐dose (12 Gy) total skin electron beam therapy (TSEBT) combined with vorinostat versus low‐dose TSEBT monotherapy in patients with mycosis fungoides. |
Participants |
Inclusion criteria
Biopsy‐confirmed mycosis fungoides (MF); clinical stage IB; IIA; IIB; or IIIB
Patients must have failed or have been intolerant to at least one prior systemic or skin‐directed therapy
18 years of age or older
Required washout period for prior therapies depending on treatment modality
Exclusion criteria
Prior courses of TSEBT (localised skin‐directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
Concomitant use of any anti‐cancer therapy or immune modifier
Prior allogeneic or autologous transplant
Proven or suspected stage IV disease including patients with B2 (Sezary syndrome); N3 (frank LN disease); or M1 (visceral disease) categories
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Interventions |
Arm I:
Arm II:
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Outcomes |
Primary outcome
Secondary outcome
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Notes |
Additional information was sought but we received no answer. |