Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

NCT03587844 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 18-147
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Mycosis Fungoides; Lymphomatoid Papulosis; Sezary Syndrome

Keywords

Brentuximab Vedotin; 18-147

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (3)

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.

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.

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.

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.

not been previously treated with brentuximab vedotin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Seagen Inc.: collaborator

Study Sites (8)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Mycosis Fungoides; Lymphomatoid Papulosis; Sezary Syndrome

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Alison Moskowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Moskowitz, MD

CONTACT

646-608-3726; moskowia@mskcc.org

Patricia Myskowski, MD

CONTACT

646-608-2351

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: July 3, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (8)