A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Registration Number
- NCT04569032
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD30-negative Cohort cyclophosphamide Participants with CD30 expression level \< 1% CD30-negative Cohort brentuximab vedotin Participants with CD30 expression level \< 1% CD30-negative Cohort prednisone Participants with CD30 expression level \< 1% CD30-negative Cohort doxorubicin Participants with CD30 expression level \< 1% CD30-positive Cohort brentuximab vedotin Participants with CD30 expression level ≥1% to \< 10% CD30-positive Cohort doxorubicin Participants with CD30 expression level ≥1% to \< 10% CD30-positive Cohort cyclophosphamide Participants with CD30 expression level ≥1% to \< 10% CD30-positive Cohort prednisone Participants with CD30 expression level ≥1% to \< 10%
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment 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 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.
- Secondary Outcome Measures
Name Time Method Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment 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 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.
Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment 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) 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.
Overall Survival (OS) by Central CD30 Assessment From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months) 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.
Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment 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) 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.
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment 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 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment 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) 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.
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 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) 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
Trial Locations
- Locations (51)
Stanford Cancer Center / Blood and Marrow Transplant Program
🇺🇸Stanford, California, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Johns Hopkins Medical Center
🇺🇸Washington, District of Columbia, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Oncology Hematology Care
🇺🇸Fairfield, Ohio, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
🇺🇸Fort Worth, Texas, United States
Texas Oncology - Northeast Texas
🇺🇸Longview, Texas, United States
Virginia Oncology Associates - Virginia Beach
🇺🇸Virginia Beach, Virginia, United States
Fakultni Nemocnice Ostrava
🇨🇿Ostrava - Poruba, Other, Czechia
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Other, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Other, Czechia
Centre Hospitalier Universitaire de Grenoble
🇫🇷La Tronche, Other, France
CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies
🇫🇷Cedex 9, Other, France
Hopital Emile Muller
🇫🇷Mulhouse, Other, France
Groupe Hospitalier du Haut Leveque
🇫🇷Pessac, Other, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
🇫🇷Rouen, Other, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, Other, France
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Other, Italy
A.O.U Policlinico G. Rodolico S. Marco
🇮🇹Catania, Other, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Other, Italy
IRCSS Policlinico San Matteo
🇮🇹Pavia, Other, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Hospital de la Santa Creu i Sant Paul
🇪🇸Barcelona, Other, Spain
L'Institut Catala d'Oncologia
🇪🇸L'Hospitalet de Llobregat, Other, Spain
MD Anderson Cancer Center - Madrid
🇪🇸Madrid, Other, Spain
Hospital Costa del Sol
🇪🇸Marbella, Other, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Other, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Other, Spain
Oxford University Hospitals
🇬🇧Headington, Other, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, Other, United Kingdom
The Royal Marsden Hospital
🇬🇧London, Other, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, Other, United Kingdom
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, Other, United Kingdom
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, Other, United Kingdom
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Other, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Other, Italy
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Other, Spain
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Candiolo Cancer Institute, FPO-IRCCS
🇮🇹Candiolo (Torino), Other, Italy
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Other, Spain
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Other, United Kingdom
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States