Clincosm LogoSign in Get a demo

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
43
Locations
2
Arms
37.6
Anticipated Duration (Months)
1.9
Patients Per Site
0
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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35249
    2 Stanford Cancer Center / Blood and Marrow Transplant Program Stanford California United States 94305
    3 Rocky Mountain Cancer Centers - Aurora Aurora Colorado United States 80012
    4 Rocky Mountain Cancer Centers - Aurora Aurora Colorado United States 80012
    5 Johns Hopkins Medical Center Washington District of Columbia United States 20016
    6 Illinois Cancer Specialists / Advocate Lutheran General Hospital Niles Illinois United States 60714
    7 Tulane University Hospital and Clinic New Orleans Louisiana United States 70112
    8 Ochsner Medical Center New Orleans Louisiana United States 70121
    9 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    10 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    11 Cleveland Clinic, The Cleveland Ohio United States 44195
    12 Oncology Hematology Care Fairfield Ohio United States 45014
    13 University of Tennessee Knoxville Tennessee United States 37920
    14 Texas Oncology - Amarillo Amarillo Texas United States 79106
    15 Texas Oncology - Austin Midtown Austin Texas United States 78705
    16 Texas Oncology - Fort Worth 12th Avenue Fort Worth Texas United States 76104
    17 MD Anderson Cancer Center / University of Texas Houston Texas United States 77030-4095
    18 Texas Oncology - Tyler Longview Texas United States 75601
    19 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
    20 Virginia Oncology Associates - Virginia Beach Virginia Beach Virginia United States 23456
    21 Fakultni Nemocnice Ostrava Ostrava - Poruba Other Czechia 708 52
    22 Fakultni Nemocnice Kralovske Vinohrady Praha 10 Other Czechia 100 34
    23 Vseobecna fakultni nemocnice v Praze Praha 2 Other Czechia 128 08
    24 CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies Cedex 9 Other France 85925
    25 Centre Hospitalier Universitaire de Grenoble La Tronche Other France 38700
    26 Hopital Emile Muller Mulhouse Other France 68100
    27 Groupe Hospitalier du Haut Leveque Pessac Other France 33604
    28 Centre Hospitalier Lyon Sud Pierre Benite Cedex Other France 69495
    29 Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer Rouen Other France 76038
    30 Azienda Ospedaliero-Universitaria di Bologna - IRCCS Bologna Other Italy 40138
    31 Azienda Ospedaliera Spedali Civili di Brescia Brescia Other Italy 25123
    32 Candiolo Cancer Institute, FPO-IRCCS Candiolo Other Italy 10060
    33 Azienda Ospedaliera Universitaria Integrata di Verona Verona Other Italy 37134
    34 Hospital de la Santa Creu i Sant Paul Barcelona Other Spain 08041
    35 L'Institut Catala d'Oncologia L'Hospitalet de Llobregat Other Spain 08907
    36 MD Anderson Cancer Center - Madrid Madrid Other Spain 28033
    37 Hospital Universitario 12 de Octubre Madrid Other Spain 28041
    38 Hospital Universitario La Paz Madrid Other Spain 28046
    39 Hospital Clinico Universitario de Salamanca Salamanca Other Spain 37007
    40 The Beatson West of Scotland Cancer Centre Glasgow Other United Kingdom G12 0YN
    41 Oxford University Hospitals Headington Other United Kingdom OX3 7LE
    42 University College London Hospitals NHS Foundation Trust London Other United Kingdom NW1 2BU
    43 Christie Hospital NHS Foundation Trust Manchester Other United Kingdom M20 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:
    Aug 17, 2022
    Last Verified:
    Aug 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.
    CD30-positive
    CD30-negative
    Seattle Genetics
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Prednisone
    Cyclophosphamide
    Doxorubicin
    Brentuximab Vedotin

    Study Results

    No Results Posted as of Aug 17, 2022