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Reduced Brentuximab Vedotin Doses in Treating Patients with Stage IB-IV Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Trial Status: Active

This phase II trial studies how well reduced brentuximab vedotin doses work in treating patients with stage IB-IV mycosis fungoides, Sezary syndrome, and lymphomatoid papulosis. Brentuximab vedotin is a monoclonal antibody called brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them.

Inclusion Criteria

  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Eastern Cooperative Oncology Group (ECOG) performance score =< 2.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: For Cohort 1, patients who have not received brentuximab vedotin are eligible.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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 principal investigator (PI).
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: If human immunodeficiency virus (HIV)+, patient must be on stable anti-retroviral treatment for 12 weeks prior to cycle 1 day 1 (C1D1), with CD4 count > 200 within 7 days prior to C1D1.
  • MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Females of childbearing potential must be on acceptable form of birth control per institutional standard.
  • LYMPHOMATOID PAPULOSIS: Pathologically confirmed CD30+ lymphomatoid papulosis at the enrolling institution.
  • LYMPHOMATOID PAPULOSIS: Requiring systemic treatment per investigator’s discretion.
  • LYMPHOMATOID PAPULOSIS: ECOG performance score =< 2.
  • LYMPHOMATOID PAPULOSIS: Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
  • LYMPHOMATOID PAPULOSIS: 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.
  • LYMPHOMATOID PAPULOSIS: 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.

Exclusion Criteria

  • 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 (creatinine clearance [CrCL] < 30 mL/min).
  • Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C).
  • Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider. * 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).
  • Previous use of brentuximab vedotin (for Cohort 1 ONLY).
  • 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 Memorial Sloan Kettering (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.

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Youn H Kim
Phone: 650-498-6000

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Niloufer Khan
Phone: 646-608-3709

PRIMARY OBJECTIVE:

I. To evaluate the overall response rate of lower dose brentuximab vedotin in patients with mycosis fungoides (MF)/Sezary syndrome (SS) who did not previously receive prior brentuximab vedotin (Cohort 1).

SECONDARY OBJECTIVES:

I. To describe the rate of neuropathy associated with lower dose brentuximab vedotin in MF/SS and lymphomatoid papulosis (LyP) (all cohorts).

II. To assess the safety profile associated with lower dose brentuximab vedotin in MF/SS and LyP (all cohorts).

III. Assess quality of life using a validated instrument (Functional Assessment of Chronic

Illness Therapy-Lymphoma [FACT-Lym], FACT/Gynecologic Oncology Group [GOG] - Neurotoxicity [NTX]-12 “Additional Concerns”, and Skindex-29) (all cohorts).

IV. To estimate the objective response rate (ORR)4 (rate of overall global response lasting >= 4 months) in MF/SS and LyP (all cohorts).

V. To estimate duration of response and progression free survival (PFS) (all cohorts).

VI. To describe the association between ORR and level of CD30 expression (all cohorts).

VII. To estimate ORR in cohorts 2 and 3.

EXPLORATORY OBJECTIVE:

I. Assess tumor cell and microenvironment changes following treatment with brentuximab vedotin to identify immunologic mechanisms of action and evaluate for markers of response and resistance.

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) over approximately 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

At completion of study treatment, patients are followed up every 3 months for 9 months, and then periodically for up to 3 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Niloufer Khan

  • Primary ID 18-147
  • Secondary IDs NCI-2018-01543
  • Clinicaltrials.gov ID NCT03587844