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New treatment option for Mycosis Fungoides
Official title Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
ClinicalTrials.gov ID: NCT03587844
What this study is testing
What is brentuximab vedotin?
brentuximab vedotin is an investigational medicine, being studied as a potential treatment for mycosis fungoides.
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
- The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.
- 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
- Mycosis fungoides (MF) and Sezary Syndrome (SS)
- Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules...
- Age ≥ 18 years
- ECOG Performance Score ≤ 2
- For Cohort 1, patients who have not received brentuximab vedotin are eligible.
You likely can't join if
- for guidelines regarding adjuvant and maintenance therapy for prior malignancy.
- Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to...
- If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1.
- Females of childbearing potential must be on acceptable form of birth control per instutional standard. Lymphomatoid papulosis (LyP)
- Pathologically confirmed lymphomatoid papulosis at the enrolling institution
- Requiring systemic treatment per investigator's discretion
See the full eligibility criteria
- Mycosis fungoides (MF) and Sezary Syndrome (SS)
- Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher ° CD30 negative...
- Age ≥ 18 years
- ECOG Performance Score ≤ 2
- For Cohort 1, patients who have not received brentuximab vedotin are eligible.
- For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2.
- Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. ° See section 6.2 Subject
- for guidelines regarding adjuvant and maintenance therapy for prior malignancy.
- Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary...
- If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1.
- Females of childbearing potential must be on acceptable form of birth control per instutional standard. Lymphomatoid papulosis (LyP)
- Pathologically confirmed lymphomatoid papulosis at the enrolling institution
- Requiring systemic treatment per investigator's discretion
- Age ≥ 18 years
- ECOG Performance Score ≤ 2
- Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
- Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary...
- If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1.
- Females of childbearing potential must be on acceptable form of birth control per institutional standard Exclusion Criteria:
- Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/sezary syndrome, or lymphomatoid papulosis.
- Grade 2 or greater neuropathy
- Severe renal impairment (CrCL \<30 mL/min)
- Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C) ° See Appendix E for Child Pugh 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 treating provider.
- Previous use of brentuximab vedotin (for Cohort 1 ONLY)
- Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma).
- Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
- Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK Principal Investigator.
- For Cohort 2, patients who previously progressed on the standard 1.8mg/kg dose and schedule of brentuximab vedotin are ineligible.
- A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- East White Plains, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 Stanford, California, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; East White Plains, New York, United States and 2 more location(s). 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.