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

NCT05357794 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0500NCI-2022-03831
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• To establish the overall response rate (ORR)

  through study completion, an average of 1 year

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

Participant will receive radiation therapy to the entire skin surface over the course of 2 days. Each dose will take about 60 to 90 minutes and will vary from one patient to another

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

Given by Vein (IV)

Also known as: SGN-35, Adcetris

Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Topical or systemic steroids (equivalent to 10 mg/day of prednisone) may be considered if the dose of such steroids has been constant and their discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with the Principal Investigator.
• years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 3 (APPENDIX 5)
• No required wash-out period for prior therapies
• HIV+ participants must be on stable antiretroviral treatment for 12 weeks before the first day of cycle 1 (C1D1), with CD4 count \>200 within the 7 days before C1D1.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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)
• Women of reproductive potential must have a negative serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with the treating provider. And agree to use adequate birth control measures (oral, implanted, or barrier methods) while on study Female participants of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception (Failure rate of \<1% per year when used consistently and correctly) throughout the total duration of the drug treatment and the drug washout period as determined by your physician. Non-sterilized male partners of a female participants of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female participants should also refrain from breastfeeding throughout this period. Highly effective contraceptive methods:
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
• oral
• intravaginal
• transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation
• oral
• injectable
• Implantable progestogen-only hormonal contraception associated with inhibition of ovulation b
• Intrauterine device (IUD)c
• Intrauterine hormone-releasing system (IUS)c

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Bouthaina Dabaja, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bouthaina Dabaja, MD

CONTACT

(713) 563-2406; bdabaja@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)