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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD30-negative Cohort | Experimental | Participants with CD30 expression level < 1% |
|
| CD30-positive Cohort | Experimental | Participants with CD30 expression level ≥1% to < 10% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle |
|
| 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 |
| 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 |
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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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham |
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Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
Participants who had newly diagnosed non-systemic anaplastic large cell lymphoma (sALCL) peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression, were enrolled to receive A+CHP treatment (brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone). Enrollment was based on CD30 expression per local laboratory assessment. Analysis of efficacy outcome measures was based on CD30 expression per central laboratory assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD30 <1% [Local Laboratory Assessment] | Participants with <1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2021 | Apr 28, 2025 |
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|
| cyclophosphamide | Drug | 750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle |
|
| doxorubicin | Drug | 50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle |
|
| prednisone | Drug | 100 mg daily administered orally on Days 1-5 of each cycle |
|
| 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) |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Stanford Hospital and Clinics, Investigational Drug Services | Stanford | California | 94305 | United States |
| Rocky Mountain Cancer centers, LLP | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer centers, LLP | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer centers, LLP | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer centers, LLP | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer centers, LLP | Denver | Colorado | 80220 | United States |
| Rocky Mountain Cancer centers, LLP | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer centers, LLP | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer centers, LLP | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer centers, LLP | Longmont | Colorado | 80504 | United States |
| Rocky Mountain Cancer centers, LLP | Pueblo | Colorado | 81003 | United States |
| Rocky Mountain Cancer centers, LLP | Thornton | Colorado | 80260 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic taussig Cancer Center Investigational Pharmacy | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| Texas Oncology - Central/South Texas | Austin | Texas | 78705 | United States |
| Texas Oncology - Central South (Balcones Dr) | Austin | Texas | 78731 | United States |
| Texas Oncology - Central South (James Casey) | Austin | Texas | 78745 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center(IPC) | Irving | Texas | 75063 | United States |
| US Oncology lnvestigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| Texas Oncology-Northeast Texas | Longview | Texas | 75601 | United States |
| Texas Oncology-Northeast Texas | Palestine | Texas | 75801 | United States |
| Texas Oncology-Northeast Texas | Paris | Texas | 75460 | United States |
| Texas Oncology-Northeast Texas | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | United States |
| Virginia Oncology Associates | Hampton | Virginia | 23666 | United States |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| VCU Massey Cancer Center-Radiation Oncology | Richmond | Virginia | 23219 | United States |
| VCU Medical Center -InPatient | Richmond | Virginia | 23219 | United States |
| VCU Medical Center Critical Care Hospital | Richmond | Virginia | 23219 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| VCU at Stony Point | Richmond | Virginia | 23235 | United States |
| Massey Cancer Center Clinical & Translational Research Lab | Richmond | Virginia | 23298 | United States |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | United States |
| CHU Grenoble Alpes | Tranche | Auvergne-Rhône-Alpes | 38700 | France |
| Hopital Emile Muller | Mulhouse | 68070 | France |
| Höpital Haut Levéque - CHU Bordeaux Service d'hématologie clinique et thérapie cellulaire | Pessac | 33604 | France |
| Azienda Ospedaliero Universitaria di Bologna - IRCCS | Bologna | Emilia-Romagna | 40138 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Fondazione Irccs San Matteo | Pavia | Lombardy | 27100 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | Other | 16132 | Italy |
| Fondazione del Piemonte per l'Oncologia (FPO) - IRCCS Candiolo - Oncologia Medica | Candiolo | Turin | 10060 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona Policlinico G.B. Rossi | Verona | 37134 | Italy |
| IEC Trials, Hospital La Milagrosa. | Madrid | Other | 28010 | Spain |
| Hospital Universitario De La Paz | Madrid | Other | 28046 | Spain |
| Cetir Centre Medic | Barcelona | 08029 | Spain |
| Hospital Duran I Reynals - Institut Catala d'Oncologia | Barcelona | 08908 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Oxford University Hospitals | Headington | Oxford | OX3 7LE | United Kingdom |
| UCLH Hospitals | London | NWI 2BG | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| MACMILLIAN Cancer Centre | London | WC1E 6AG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| FG001 | CD30 1% to <10% [Local Laboratory Assessment] | Participants with 1% to <10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CD30 <1% [Local Laboratory Assessment] | Participants with <1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
| BG001 | CD30 1% to <10% [Local Laboratory Assessment] | Participants with 1% to <10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
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| Secondary | 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. | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 | 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. | Not Posted | Dec 2025 | 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) | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Dec 2025 | From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months) | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Dec 2025 | 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) | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 | 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. | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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 | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, "Overall Number of Participants Analyzed" were participants evaluable for this outcome measure however all participants reported under "Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows. | Posted | Count of Participants | Participants | 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) |
|
Adverse events: From first dose of the study treatment (Day 1) maximum up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months). All-cause mortality: throughout the study (up to 41 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Results are reported based on participants classified per local laboratory assessment for CD30 expression.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD30 <1% [Local Laboratory Assessment] | Participants with <1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. | 11 | 34 | 15 | 34 | 31 | 34 |
| EG001 | CD30 1% to <10% [Local Laboratory Assessment] | Participants with 1% to <10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. | 13 | 48 | 16 | 48 | 43 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cutaneous T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2021 | Apr 28, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| OG001 | CD30 1% to <10% [Local Laboratory Assessment] | Participants with 1% to <10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
|
|
| OG000 |
| CD30 <1% [Local Laboratory Assessment] |
Participants with <1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
| OG001 | CD30 1% to <10% [Local Laboratory Assessment] | Participants with 1% to <10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. |
|
|