Mycosis FungoidesPhase 2NCT05357794
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
A Phase 2 study testing Brentuximab vedotin in people with Mycosis Fungoides, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Brentuximab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 30 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age or older
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- 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.
Who cannot join
- 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
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- 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
- Bilateral tubal occlusion
- Surgical Sterilization
- Receipt of systemic therapy for another primary malignancy (other than T-cell lymphoma). Participants with more than one type of lymphoma may be enrolled after discussion with the Principal Investigator
- Underlying medical conditions including unstable cardiac disease, or other serious illness that would impair the ability of participants to undergo treatment
- Any other medical history, including laboratory results, deemed by the Principal Investigator to be likely to interfere with participants participation in the study
- Use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, should be avoided given the potential effect on exposure to monomethyl auristatin E.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Bouthaina Dabaja, MD, 713-563-2406, bdabaja@mdanderson.org
Bouthaina Dabaja, MD
About this study
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
Read the detailed description
OBJECTIVES:
Primary Objective:
The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome.
Secondary Objective:
Key secondary objective is to determine the time to treatment failure (TTF) Determine the safety of brentuximab vedotin (BV) with fractionated ultra-low-dose-total-skin electron beam therapy (ULD-TSEBT) Describe the rate and grade of neuropathy associated with lower-dose BV by using CTCAE V5.0 Assess quality of life by using the validated Skindex-29 instrument and FACT instrument Determine the complete response rate (CRR) Determine progression-free survival (PFS) Determine overall survival (OS) Note: The study follow up timeframe for CRR, PFS and OS is expected to be two and half years.
Assess the relationship between ORR and CD30 expression level
Exploratory Objectives:
Objective: To identify tumor and peripheral blood markers that predict response to concurrent BV with fractionated ULD-TSEBT, including SS component in the history.
Objective: Identification of tumor and peripheral blood markers that are predictive of response to the combination therapy. Define changes in the TCR clonotypes, phenotypes, and inflammatory cytokine levels in biopsy specimens, peripheral blood leukocytes, and serum. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.
- Conditions
- Mycosis Fungoides
- Being tested
- Brentuximab vedotin
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab vedotinDrug
Also called SGN-35, Adcetris
Given by Vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the overall response rate (ORR)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start13 Oct 2022
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bouthaina Dabaja, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357794
- Sponsor's protocol ID
- 2021-0500
- Other IDs
- NCI-2022-03831
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
- ClinicalTrials.gov ID
- NCT05357794
- Acronym / sponsor ID
- 2021-0500
- Conditions
- Mycosis Fungoides
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
Primary Objective:
The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome.
Secondary Objective:
Key secondary objective is to determine the time to treatment failure (TTF) Determine the safety of brentuximab vedotin (BV) with fractionated ultra-low-dose-total-skin electron beam therapy (ULD-TSEBT) Describe the rate and grade of neuropathy associated with lower-dose BV by using CTCAE V5.0 Assess quality of life by using the validated Skindex-29 instrument and FACT instrument Determine the complete response rate (CRR) Determine progression-free survival (PFS) Determine overall survival (OS) Note: The study follow up timeframe for CRR, PFS and OS is expected to be two and half years.
Assess the relationship between ORR and CD30 expression level
Exploratory Objectives:
Objective: To identify tumor and peripheral blood markers that predict response to concurrent BV with fractionated ULD-TSEBT, including SS component in the history.
Objective: Identification of tumor and peripheral blood markers that are predictive of response to the combination therapy. Define changes in the TCR clonotypes, phenotypes, and inflammatory cytokine levels in biopsy specimens, peripheral blood leukocytes, and serum. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin | Experimental | Drug: Brentuximab vedotinParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab vedotinAlso: SGN-35, AdcetrisGiven by Vein (IV) | Drug | Brentuximab vedotin |
Primary outcome
To establish the overall response rate (ORR)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bouthaina Dabaja, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brentuximab vedotin in people with Mycosis Fungoides, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bouthaina Dabaja, MD ((713) 563-2406, bdabaja@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the overall response rate (ORR) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.