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. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Bashey 2014.

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

Interventions Arm I:
  • TSEBT & Vorinostat


Arm II:
  • TSEBT only

Outcomes Primary outcome
  • Complete clinical response (CCR) at week 8


Secondary outcome
  • Safety and tolerability

  • Clinical response rate (CRR)

  • Duration of clinical benefit

Notes Additional information was sought but we received no answer.