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Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587844
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Lymphomatoid Papulosis Sezary Syndrome Drug: brentuximab vedotin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
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.
Drug: brentuximab vedotin
MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.

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.
Drug: brentuximab vedotin
MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1

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.
Drug: brentuximab vedotin
LyP Brentuximab vedotin 0.9 mg/kg2




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587844


Contacts
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Contact: Niloufer Khan, MD, MS 646-608-3709 khann2@mskcc.org
Contact: Alison Moskowitz, MD 646-608-3726

Locations
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United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305-5408
Contact: Youn Kim, MD    650-498-6000      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Niloufer Khan, MD, MS    646-608-3709      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Niloufer Khan, MD, MS    646-608-3709      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Niloufer Khan, MD, MS    646-608-3709      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Niloufer Khan, MD, MS    646-608-3709      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Niloufer Khan, MD, MS    646-608-3709      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Niloufer Khan, MD, MS    646-608-3709      
Contact: Alison Moskowitz, MD    646-608-3726      
Principal Investigator: Niloufer Khan, MD,MS         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Niloufer Khan, MD, MS    646-608-3709      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Seagen Inc.
Investigators
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Principal Investigator: Niloufer Khan, MD, MS Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03587844    
Other Study ID Numbers: 18-147
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Brentuximab Vedotin
18-147
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphomatoid Papulosis
Syndrome
Disease
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs