Clinical Trials /

Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

NCT03587844

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.

Related Conditions:
  • Lymphomatoid Papulosis
  • Mycosis Fungoides
  • Sezary Syndrome
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
  • Official Title: Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Clinical Trial IDs

  • ORG STUDY ID: 18-147
  • NCT ID: NCT03587844

Conditions

  • Mycosis Fungoides
  • Lymphomatoid Papulosis
  • Sezary Syndrome

Interventions

DrugSynonymsArms
brentuximab vedotinnot been previously treated with brentuximab vedotin.
brentuximab vedotinPatients with LyP
brentuximab vedotintreated with reduced dose brentuximab vedotin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
not been previously treated with brentuximab vedotin.ExperimentalPatients 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.
  • brentuximab vedotin
treated with reduced dose brentuximab vedotinExperimentalPatients 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.
  • brentuximab vedotin
Patients with LyPExperimentalPatients 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.
  • brentuximab vedotin

Eligibility Criteria

        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 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.

        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.

                    -  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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall response
Time Frame:1 year
Safety Issue:
Description: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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Brentuximab Vedotin
  • 18-147

Last Updated

September 4, 2019