Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy \[ULD-TSEBT\]) in combination with brentuximab vedotin can help to control mycosis fungoides

Eligibility criteria

Qualifiers

Biopsy-confirmed mycosis fungoides in stage I-IV (APPENDICES 3 AND 4); the presence of Sezary cells in the blood is acceptable at original diagnosis or at enrollment into the protocol, as long as the patient has current mycosis fungoides in the skin and the sesary cells in peripheral blood are < 1000 cells/ microlitre at the time of enrollment.

Participants with relapsed/ refractory mycosis fungoides expressing at least 1% CD30 are eligible.

Previous systemic anticancer therapy must have been discontinued at least 1 week before treatment

In the case of myelosuppressive chemotherapy treatment may start once counts have recovered including absolute WBC> 1000, platelets> 50K.

Disqualifiers

Concurrent use of other systemic anticancer agents or treatments (including steroids unless adrenal insufficiency has been diagnosed) for mycosis fungoides or Sezary syndrome

Grade 2 or greater neuropathy

Severe renal impairment (creatinine clearance [CrCL] <30 mL/min)

Moderate or severe hepatic impairment (Child-Pugh B or C; see APPENDIX 6 for ChildPugh classification chart)

Trial design

Treatments tested in this trial

  • Brentuximab vedotin

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators