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.
Full Title of Study: “Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2021
- Drug: brentuximab vedotin
- MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
- Drug: brentuximab vedotin
- LyP Brentuximab vedotin 0.9 mg/kg2
- Drug: brentuximab vedotin
- MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1
Arms, Groups and Cohorts
- 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.
- 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. If neither dose is found promising, cohort 2 will not start. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study.
- 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.
Clinical Trial Outcome Measures
- overall response
- Time Frame: 1 year
- 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
Participating in This Clinical Trial
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 and achieved at least a partial response are eligible. Patients previously treated on Cohort 1 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.
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.
- 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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Seattle Genetics, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Alison Moskowitz, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
- Overall Contact(s)
- Alison Moskowitz, MD, 212-639-4839, firstname.lastname@example.org
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