Clinical trial NCT04569032: A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: CD30-positive
CD30-negative
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
timeFrame: 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 outcomes:
measure: Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment
timeFrame: 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
measure: Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment
timeFrame: 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)
measure: Overall Survival (OS) by Central CD30 Assessment
timeFrame: From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)
measure: Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment
timeFrame: 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)
measure: ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
timeFrame: 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
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment
timeFrame: 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)
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford Cancer Center / Blood and Marrow Transplant Program
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Washington
country: United States
facility: Johns Hopkins Medical Center
state: District of Columbia
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic, The
state: Ohio
city: Fairfield
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth 12th Avenue
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates - Virginia Beach
state: Virginia
city: Ostrava - Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
state: Other
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
state: Other
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
state: Other
city: Cedex 9
country: France
facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies
state: Other
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
state: Other
city: Mulhouse
country: France
facility: Hopital Emile Muller
state: Other
city: Pessac
country: France
facility: Groupe Hospitalier du Haut Leveque
state: Other
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
state: Other
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
state: Other
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
state: Other
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
state: Other
city: Candiolo (Torino)
country: Italy
facility: Candiolo Cancer Institute, FPO-IRCCS
state: Other
city: Catania
country: Italy
facility: A.O.U Policlinico G. Rodolico S. Marco
state: Other
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
state: Other
city: Pavia
country: Italy
facility: IRCSS Policlinico San Matteo
state: Other
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
state: Other
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Paul
state: Other
city: L'Hospitalet de Llobregat
country: Spain
facility: L'Institut Catala d'Oncologia
state: Other
city: Madrid
country: Spain
facility: MD Anderson Cancer Center - Madrid
state: Other
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Other
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Other
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Other
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
state: Other
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Other
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
state: Other
city: Headington
country: United Kingdom
facility: Oxford University Hospitals
state: Other
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: Other
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
state: Other
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Other
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
state: Other
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital (Surrey)
state: Other
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: