Could a lower dose of this cancer drug be just as good?
NCT ID NCT03587844
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a lower dose of the drug brentuximab vedotin can still effectively treat three types of skin lymphoma: mycosis fungoides, Sezary syndrome, and lymphomatoid papulosis. The goal is to see if reducing the dose can maintain benefits while possibly lowering side effects. About 58 adults with these conditions are being enrolled to compare different dosing schedules.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin
- What this could lead to
- If successful, this could show that a lower dose of brentuximab vedotin is still effective for these skin lymphomas while causing fewer side effects.
- What could go wrong
- This is a small Phase 2 trial with only 58 participants, so results may not apply to everyone. Lower doses might also be less effective at controlling the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Mycosis fungoides (MF) and Sezary Syndrome (SS) 1. 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 mycosis fungoides patients are eligible. 2. Age ≥ 18 years 3. ECOG Performance Score ≤ 2 4. For Cohort 1, patients who have not received brentuximab vedotin are eligible. 5. 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. 6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. ° See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy. 7. 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 suffering, after discussion with PI. 8. 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. 9. Females of childbearing potential must be on acceptable form of birth control per instutional standard. Lymphomatoid papulosis (LyP) 1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution 2. Requiring systemic treatment per investigator's discretion 3. Age ≥ 18 years 4. ECOG Performance Score ≤ 2 5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. 6. 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 suffering. 7. 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. 8. Females of childbearing potential must be on acceptable form of birth control per institutional standard Exclusion Criteria: 1. Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/sezary syndrome, or lymphomatoid papulosis. 2. Grade 2 or greater neuropathy 3. Severe renal impairment (CrCL \<30 mL/min) 4. Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C) ° See Appendix E for Child Pugh Classification chart 5. 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. 6. Previous use of brentuximab vedotin (for Cohort 1 ONLY) 7. 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. 8. 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 menses at any time in the preceding 24 consecutive months).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGEast White Plains, New York, 10604, United States
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Stanford University Medical Center
RECRUITINGStanford, California, 94305-5408, United States
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