Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Conditions

• Lymphomatoid Papulosis
• Mycosis Fungoides
• Sezary Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• brentuximab vedotin — DRUG
  MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
• brentuximab vedotin — DRUG
  LyP Brentuximab vedotin 0.9 mg/kg2
• brentuximab vedotin — DRUG
  MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1

Study Details

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.

Key Dates

Start date

Jul 3, 2018

Status verified

Apr 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

58 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: not been previously treated with brentuximab vedotin.
  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.
• Experimental: treated with reduced dose brentuximab vedotin
  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.
• Experimental: Patients with LyP
  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.

Primary Outcome Measure

overall response [ Time Frame: 1 year ]

Central Contacts

• Alison Moskowitz, MD
  646-608-3726
  [email protected]
• Patricia Myskowski, MD
  646-608-2351

Locations (8)

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