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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: brentuximab vedotin; Drug: cyclophosphamide; Drug: doxorubicin; Drug: prednisone

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Mulhouse, France, 68070
    • Hôpital Emile Muller
  • Pessac, France, 33604
    • Höpital Haut Levéque - CHU Bordeaux Service d'hématologie clinique et thérapie cellulaire
  • Auvergne-Rhône-Alpes
    • Tranche, Auvergne-Rhône-Alpes, France, 38700
      • Chu Grenoble Alpes
• Italy
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata Verona Policlinico G.B. Rossi
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero Universitaria di Bologna - IRCCS
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Pavia, Lombardy, Italy, 27100
      • Fondazione Irccs San Matteo
  • Other
    • Genova, Other, Italy, 16132
      • IRCCS Ospedale Policlinico San Martino
  • Turin
    • Candiolo, Turin, Italy, 10060
      • Fondazione del Piemonte per l'Oncologia (FPO) - IRCCS Candiolo - Oncologia Medica
• Spain
  • Barcelona, Spain, 08029
    • Cetir Centre Medic
  • Barcelona, Spain, 08908
    • Hospital Duran I Reynals - Institut Catala d'Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Other
    • Madrid, Other, Spain, 28010
      • IEC Trials, Hospital La Milagrosa.
    • Madrid, Other, Spain, 28046
      • Hospital Universitario de La Paz
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • London, United Kingdom, NWI 2BG
    • UCLH Hospitals
  • London, United Kingdom, WC1E 6AG
    • MACMILLIAN Cancer Centre
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Oxford University Hospitals
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • California
    • Stanford, California, United States, 94305
      • Stanford Cancer Center
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics, Investigational Drug Services
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers, LLP
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers, LLP
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers, LLP
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers, LLP
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers, LLP
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers, LLP
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers, LLP
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers, LLP
    • Longmont, Colorado, United States, 80504
      • Rocky Mountain Cancer Centers, LLP
    • Pueblo, Colorado, United States, 81003
      • Rocky Mountain Cancer Centers, LLP
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers, LLP
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, The
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Central South (Balcones Dr)
    • Austin, Texas, United States, 78745
      • Texas Oncology - Central South (James Casey)
    • Austin, Texas, United States, 78705
      • Texas Oncology - Central/South Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology lnvestigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center(IPC)
    • Longview, Texas, United States, 75601
      • Texas Oncology-Northeast Texas
    • Palestine, Texas, United States, 75801
      • Texas Oncology-Northeast Texas
    • Paris, Texas, United States, 75460
      • Texas Oncology-Northeast Texas
    • Tyler, Texas, United States, 75702
      • Texas Oncology-Northeast Texas
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Virginia Oncology Associates
    • Hampton, Virginia, United States, 23666
      • Virginia Oncology Associates
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23298
      • Massey Cancer Center Clinical & Translational Research Lab
    • Richmond, Virginia, United States, 23219
      • VCU Massey Cancer Center-Radiation Oncology
    • Richmond, Virginia, United States, 23219
      • VCU Medical Center -InPatient
    • Richmond, Virginia, United States, 23219
      • VCU Medical Center Critical Care Hospital
    • Richmond, Virginia, United States, 23235
      • VCU at Stony Point
    • Virginia Beach, Virginia, United States, 23456
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment	ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment [EOT]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.	At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment	CR rate was defined as the percentage of participants with CR following the completion of study treatment (at EOT). CR as per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.	At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment	PFS was defined as the time from start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever came first. Kaplan-Meier method was used for analysis. PFS data was censored on the date of the last radiological assessment of measured lesions documenting absence of PD for participants without objective tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment or stem cell transplant (included donor lymphocyte infusion) or were removed from study prior to documentation of objective tumor progression. Participants who lacked an evaluation of tumor response after their first dose had their event time censored at 1 day.	From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months)
Overall Survival (OS) by Central CD30 Assessment	OS was defined as the time from first dose to death due to any cause. Participant not known to have died by the end of study follow-up, observation of OS was censored on the date the participants were last known to be alive (i.e., date of last contact). Participants who lacked data beyond the day of first dose had their survival time censored on the date of first dose (i.e., OS duration of 1 day). Kaplan-Meier method was used for analysis.	From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)
Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment	DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (per Cheson 2007) or death, whichever came first. Participants without progression or death were censored. DOR was only calculated for the subset of participants achieving a CR or PR. CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Kaplan-Meier method was used for analysis.	From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months)
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment	ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.	At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment	An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.	From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment	Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE	From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): May 9, 2024
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Seattle Genetics; CD30-positive; CD30-negative
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Peripheral; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Proteins; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Brentuximab Vedotin; Prednisone; Cyclophosphamide; Doxorubicin
• Other Study ID Numbers: SGN35-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No