RECRUITING

Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Conditions

Mycosis Fungoides Lymphomatoid Papulosis Sezary Syndrome Brentuximab Vedotin 18-147

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-07-03

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03587844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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. 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. 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	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) 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).

Inclusion Criteria

Exclusion Criteria

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
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.
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.
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

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)
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).

Contacts and Locations

Study Contact

Alison Moskowitz, MD

CONTACT

646-608-3726

moskowia@mskcc.org

Patricia Myskowski, MD

CONTACT

646-608-2351

Principal Investigator

Alison Moskowitz, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Stanford University Medical Center

Stanford, California, 94305-5408

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Alison Moskowitz, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-03

Study Completion Date2025-07

Study Record Updates

Study Start Date2018-07-03

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Brentuximab Vedotin
18-147

Additional Relevant MeSH Terms

Mycosis Fungoides
Lymphomatoid Papulosis
Sezary Syndrome