A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03947255
Collaborator
(none)
80
Enrollment
19
Locations
1
Arm
62.1
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: brentuximab vedotin
Phase 2

Detailed Description

This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
Actual Study Start Date :
Oct 28, 2019
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Brentuximab vedotin

Drug: brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Names:
  • ADCETRIS
  • SGN-35
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 1 year]

    2. Number of participants with adverse events [Up to approximately 5 years]

    3. Number of participants with laboratory abnormalities [Up to approximately 1 year]

    Secondary Outcome Measures

    1. Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

    2. Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

    3. Overall survival (OS) [Up to approximately 5 years]

    4. Rate of complete response (CR) per BICR according to modified Lugano response criteria [Up to approximately 1 year]

    5. ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 1 year]

    6. DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

    7. PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

    8. Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

    9. ORR per BICR according to Lugano response criteria (Cheson 2014) [Up to approximately 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL

    • Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment

    • Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin

    • Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique

    • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2

    • Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

    Exclusion Criteria:
    • Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity

    • Existing Grade 2 or higher peripheral neuropathy

    • Previously refractory to treatment with brentuximab vedotin

    • History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose

    • History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy

    • Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD

    • Active cerebral/meningeal disease

    • History of progressive multifocal leukoencephalopathy (PML)

    • Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug

    • Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Pacific Cancer Medical CenterAnaheimCaliforniaUnited States92801
    2SCL Health Good Samaritan Medical Center Cancer Centers of ColoradoLafayetteColoradoUnited States80026
    3Memorial Cancer InstitutePembroke PinesFloridaUnited States33028
    4Northwest Oncology and Hematology/AMITAElk Grove VillageIllinoisUnited States60007
    5Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywoodIllinoisUnited States60153
    6Norton Cancer InstituteLouisvilleKentuckyUnited States40207
    7Tulane University Hospital and ClinicNew OrleansLouisianaUnited States70112
    8University of MarylandBaltimoreMarylandUnited States21201
    9Karmanos Cancer Institute / Wayne State UniversityDetroitMichiganUnited States48201
    10Saint Louis UniversitySaint LouisMissouriUnited States63103
    11Comprehensive Cancer Centers of NevadaLas VegasNevadaUnited States89169
    12Summit Medical GroupFlorham ParkNew JerseyUnited States07932
    13Medical University of South Carolina/Hollings Cancer CenterCharlestonSouth CarolinaUnited States29425
    14Texas Oncology - Fort WorthDallasTexasUnited States75246
    15Texas Oncology - Fort Worth 12th AvenueFort WorthTexasUnited States76104
    16The Center for Cancer and Blood Disorders: FortworthFort WorthTexasUnited States76104
    17MD Anderson Cancer Center / University of TexasHoustonTexasUnited States77030-4095
    18Houston Methodist Cancer CenterHoustonTexasUnited States77030
    19Texas Oncology - San Antonio Medical CenterSan AntonioTexasUnited States78240

    Sponsors and Collaborators

    • Seagen Inc.

    Investigators

    • Study Director: Dominic Lai, MD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT03947255
    Other Study ID Numbers:
    • SGN35-028
    First Posted:
    May 13, 2019
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seagen Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 23, 2021