Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Mycosis Fungoides Clinical Trial

Official title:

Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03587844
• Other study ID #: 18-147
• Status: Recruiting
• Phase: Phase 2
• Start date: July 3, 2018
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alison Moskowitz, MD
• Phone: 646-608-3726
• Email: moskowia[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lymphomatoid Papulosis
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford University Medical Center	Stanford	California
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center