Mycosis FungoidesPhase 2NCT03587844
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
A Phase 2 study testing brentuximab vedotin in people with Mycosis Fungoides and Lymphomatoid Papulosis, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Lymphomatoid Papulosis, Sezary Syndrome
- 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
- 58 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Jul 2018to Jul 2027
- Phase
- Phase 2
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
- 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 mycosis fungoides patients are eligible.
- Age ≥ 18 years
- ECOG Performance Score ≤ 2
- For Cohort 1, patients who have not received brentuximab vedotin are eligible.
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- 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 Exclusion Criteria 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 suffering, after discussion with PI.
- 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 suffering.
- 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
Who cannot join
- 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.
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- 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 menses at any time in the preceding 24 consecutive months).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Patricia Myskowski, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Alison Moskowitz, MD, 646-608-3726
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Alison Moskowitz, MD, 646-608-3726
- Recruiting
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Alison Moskowitz, MD, 646-608-3726
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Alison Moskowitz, MD, 646-608-3726
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Alison Moskowitz, MD, 646-608-3726
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alison Moskowitz, MD, 646-608-3726
Patricia Myskowski, MD, 646-608-2351
- Recruiting
Stanford University Medical Center
Stanford, California, 94305-5408
Youn Kim, MD, (650) 498-6000
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Alison Moskowitz, MD, 646-608-3726
About this study
Official title: Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis
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.
- Conditions
- Mycosis Fungoides, Lymphomatoid Papulosis, Sezary Syndrome
- Being tested
- brentuximab vedotin
- Keywords
- Brentuximab Vedotin, 18-147
- Medical subject headings
- Mycosis Fungoides, Lymphomatoid Papulosis, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
brentuximab vedotinDrug
LyP Brentuximab vedotin 0.9 mg/kg2
brentuximab vedotinDrug
MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1
| Study group | Role | What they receive |
|---|---|---|
| not been previously treated with brentuximab vedotin. | Experimental | Patients with MF/SS who have not been previously treated with brentuximab vedotin. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. As of October 2020, the Simon two stage design for Cohort 1 has restarted at the 1.2 mg/kg dose. Receives: Drug: brentuximab vedotin |
| treated with reduced dose brentuximab vedotin | Experimental | Patients with MF/SS who were previously treated with brentuximab vedotin. Up to 10 patients will be enrolled onto this cohort. Following identification of a promising dose after the completion of the full Cohort 1 Simon two stage design, enrollment will initiate onto cohort 2 at the dose found to be promising in cohort 1. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. The 0.9mg/kg dose did not meet the primary endpoint for response, therefore 1.2 mg/kg has been chosen as the dose for Cohort 2. As of October 2020, enrollment on our exploratory Cohort 2 has opened at the 1.2 mg/kg dose. Receives: Drug: brentuximab vedotin |
| Patients with LyP | Experimental | Patients with LyP patients with lymphomatoid papulosis will receive brentuximab vedotin 0.9 mg/kg as an intravenous infusion over 30 minutes every three weeks. Cohort 3 will enroll patients concurrently with Cohort 1. Treatment may be held if felt to be in patient's best interest (for example: for toxicity or no active disease). Treatment can be reinitiated after discussion with MSK PI as long as the study is still open and patient has not received alternate systemic therapy. Receives: Drug: brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response
measure best overall response during treatment by the global response score, which incorporates the mSWAT, as well as CT scan for patients with baseline nodal/visceral involvement and flow cytometry for patients with baseline positive peripheral flow cytometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start3 Jul 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 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 Memorial Sloan Kettering 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Following identification of a promising dose after the completion of the full Cohort 1 Simon two stage design, enrollment will initiate onto cohort 2 at the dose found to be promising in cohort 1. If neither dose is found promising, cohort 2 will not start.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Alison Moskowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587844
- Sponsor's protocol ID
- 18-147
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2018
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No