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Tests treatment safety and results for Mycosis Fungoides
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
What this study is testing
What is Brentuximab vedotin?
Brentuximab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mycosis fungoides.
Also referred to as SGN-35, Adcetris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join if
- Concurrent use of other systemic anticancer agents or treatments (including steroids unless adrenal insufficiency has been diagnosed) for mycosis...
- 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...
- Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
See the full eligibility criteria
- 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...
- 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...
- 18 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.
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.