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
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Pfizer
Collaborator