A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04569032
Collaborator
(none)
80
Enrollment
40
Locations
2
Arms
37.6
Anticipated Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression
Actual Study Start Date :
Nov 12, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: CD30-negative Cohort

Participants with CD30 expression level < 1%

Drug: brentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
Other Names:
  • ADCETRIS
  • Drug: cyclophosphamide
    750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

    Drug: doxorubicin
    50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

    Drug: prednisone
    100 mg daily administered orally on Days 1-5 of each cycle

    Experimental: CD30-positive Cohort

    Participants with CD30 expression level ≥1% to < 10%

    Drug: brentuximab vedotin
    1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    Other Names:
  • ADCETRIS
  • Drug: cyclophosphamide
    750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

    Drug: doxorubicin
    50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

    Drug: prednisone
    100 mg daily administered orally on Days 1-5 of each cycle

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) per blinded independent central review (BICR) using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007) [From start of study treatment up to approximately 7 months]

      ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) at the completion of study treatment

    Secondary Outcome Measures

    1. Complete response (CR) rate per BICR [From start of study treatment up to approximately 7 months]

      CR rate is defined as the proportion of participants with CR following the completion of study treatment using Revised Response Criteria of Malignant Lymphoma (Cheson 2007).

    2. Progression-free survival (PFS) per BICR [Up to approximately 3 years]

      Time from start of treatment to the first documented disease progression or death from any cause, whichever comes first

    3. Overall survival [Up to approximately 3 years]

      Time from first dose to death due to any cause

    4. Duration of response (DOR) per BICR [Approximately 3 years]

      Time from first occurrence of an objective response to the date of disease progression or death from any cause, whichever comes first

    5. ORR per BICR per modified Lugano criteria (Cheson 2014) [From start of study treatment up to approximately 7 months]

      ORR is defined as the proportion of participants with CR or PR at the completion of study treatment

    6. Incidence of adverse events [From start of study treatment up to approximately 7 months]

      An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment

    7. Incidence of laboratory abnormalities [From start of study treatment up to approximately 7 months]

      To be summarized using descriptive statistics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification

    • The following non-sALCL PTCL subtypes are eligible:

    • PTCL - not otherwise specified (PTCL-NOS)

    • Angioimmunoblastic T-cell lymphoma (AITL)

    • Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)

    • Enteropathy-associated T-cell lymphoma (EATL)

    • Hepatosplenic T-cell lymphoma

    • Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)

    • Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract

    • Follicular T-cell lymphoma

    • Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype

    • CD30 expression <10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy

    • Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist

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

    Exclusion Criteria

    • Current diagnosis of any of the following:

    • sALCL

    • Primary cutaneous T-cell lymphoproliferative disorders and lymphomas

    • Mycosis fungoides (MF), including transformed MF

    • History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.

    • History of progressive multifocal leukoencephalopathy (PML).

    • Cerebral/meningeal disease related to the underlying malignancy.

    • Prior treatment with brentuximab vedotin or doxorubicin.

    • Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome.

    • Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of >300 mg/m2 of doxorubicin.

    • Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35249
    2Stanford Cancer Center / Blood and Marrow Transplant ProgramStanfordCaliforniaUnited States94305
    3Rocky Mountain Cancer Centers - AuroraAuroraColoradoUnited States80012
    4Rocky Mountain Cancer Centers - AuroraAuroraColoradoUnited States80012
    5Johns Hopkins Medical CenterWashingtonDistrict of ColumbiaUnited States20016
    6Illinois Cancer Specialists / Advocate Lutheran General HospitalNilesIllinoisUnited States60714
    7Tulane University Hospital and ClinicNew OrleansLouisianaUnited States70112
    8Ochsner Medical CenterNew OrleansLouisianaUnited States70121
    9University of Michigan Comprehensive Cancer CenterAnn ArborMichiganUnited States48109
    10Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
    11Cleveland Clinic, TheClevelandOhioUnited States44195
    12Oncology Hematology CareFairfieldOhioUnited States45014
    13University of TennesseeKnoxvilleTennesseeUnited States37920
    14Texas Oncology - AmarilloAmarilloTexasUnited States79106
    15Texas Oncology - Austin MidtownAustinTexasUnited States78705
    16Texas Oncology - Fort Worth 12th AvenueFort WorthTexasUnited States76104
    17MD Anderson Cancer Center / University of TexasHoustonTexasUnited States77030-4095
    18Texas Oncology - TylerLongviewTexasUnited States75601
    19Virginia Commonwealth University Medical CenterRichmondVirginiaUnited States23298
    20Virginia Oncology Associates - Virginia BeachVirginia BeachVirginiaUnited States23456
    21CHD Vendee, Site de La Roche-sur-Yon, Les OudairiesCedex 9OtherFrance85925
    22Centre Hospitalier Universitaire de GrenobleLa TroncheOtherFrance38700
    23Hopital Emile MullerMulhouseOtherFrance68100
    24Groupe Hospitalier du Haut LevequePessacOtherFrance33604
    25Centre Hospitalier Lyon SudPierre Benite CedexOtherFrance69495
    26Centre Henri Becquerel / Centre Regional de Lutte Contre le CancerRouenOtherFrance76038
    27Azienda Ospedaliero-Universitaria di Bologna - IRCCSBolognaOtherItaly40138
    28Azienda Ospedaliera Spedali Civili di BresciaBresciaOtherItaly25123
    29Candiolo Cancer Institute, FPO-IRCCSCandioloOtherItaly10060
    30Azienda Ospedaliera Universitaria Integrata di VeronaVeronaOtherItaly37134
    31Hospital de la Santa Creu i Sant PaulBarcelonaOtherSpain08041
    32Institut Catala D'Oncologia HospitaletBarcelonaOtherSpain08907
    33MD Anderson Cancer Center - MadridMadridOtherSpain28033
    34Hospital Universitario 12 de OctubreMadridOtherSpain28041
    35Hospital Universitario La PazMadridOtherSpain28046
    36Hospital Clinico Universitario de SalamancaSalamancaOtherSpain37007
    37The Beatson West of Scotland Cancer CentreGlasgowOtherUnited KingdomG12 0YN
    38Oxford University HospitalsHeadingtonOtherUnited KingdomOX3 7LE
    39University College London Hospitals NHS Foundation TrustLondonOtherUnited KingdomNW1 2BU
    40Christie Hospital NHS Foundation TrustManchesterOtherUnited KingdomM20 4BX

    Sponsors and Collaborators

    • Seagen Inc.

    Investigators

    • Study Director: Scott Knowles, MD, PhD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT04569032
    Other Study ID Numbers:
    • SGN35-032
    First Posted:
    Sep 29, 2020
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Apr 5, 2022