This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL. The main aims of the study are to evaluate: * Side effect from the A+CHP * Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future. * If A+CHP improves outcome of newly diagnosed CD30+ PTCL Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat CD30+ PTCL in Chinese participants. This study will look at the efficacy, safety, and pharmacokinetics (PK) of A+CHP as frontline treatment for newly diagnosed CD30+ PTCL. The study will enroll approximately 52 participants. Participants will be enrolled in a single group to receive: • Brentuximab vedotin 1.8 milligrams per kilogram (mg/kg) + Cyclophosphamide 750 milligrams per square meter (mg/m\^2), Doxorubicin 50 mg/m\^2 and Prednisone 100 mg This multi-center trial will be conducted in China. The overall time to participate in this study is approximately 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Brentuximab vedotin IV infusion
Cyclophosphamide IV infusion
Doxorubicin IV infusion
Prednisone tablets
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial Peoples Hospital
Guangzhou, China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, China
Anhui Provincial Cancer Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
...and 6 more locations
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment per Revised Response Criteria for Malignant Lymphoma
ORR by IRF assessment following the completion of study treatment is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Time frame: Up to approximately 7 months
Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment.
Time frame: Up to approximately 7 months
Percentage of Participants With Clinically Significant Laboratory Test Values
Clinical laboratory tests will include hematocrit, hemoglobin, platelet (count), white blood cell (WBC) count, absolute neutrophil count (ANC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (total), albumin, alkaline phosphatase, blood urea nitrogen, calcium, chloride, gamma glutamyl transferase, glucose, lactate dehydrogenase, phosphate, potassium, sodium, urate and creatinine evaluations. Any value outside the normal range will be flagged for the attention of the investigator who will assess whether or not a flagged value is of clinical significance.
Time frame: Up to approximately 7 months
Percentage of Participants With Clinically Significant Vital Signs
Vital signs will include measurements of diastolic and systolic blood pressure, heart rate, and body temperature. Any value outside the normal range will be flagged for the attention of the investigator who will assess whether or not a flagged value is of clinical significance.
Time frame: Up to approximately 7 months
CR Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
CR rate by IRF assessment following the completion of study treatment is defined as the proportion of participants who have achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR is defined as disappearance of all evidence of disease.
Time frame: Up to approximately 7 months
1-Year Progression Free Survival (PFS) Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time frame: Up to approximately 12 months
1-Year Overall Survival (OS) Rate
The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.
Time frame: Up to approximately 12 months
ORR by IRF and Investigator Assessment per 2014 Lugano Classification
ORR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses are defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) by IRF and investigator assessment following the completion of study treatment.
Time frame: Up to approximately 7 months
CR Rate by IRF and Investigator Assessment per 2014 Lugano Classification
CR rate by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by IRF and investigator assessment following the completion of study treatment.
Time frame: Up to approximately 7 months
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Time to Response (TTR) by IRF and Investigator Assessment per 2014 Lugano Classification
TTR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses=time from date of first study drug administration to date of first documented objective response(CR or PR) by IRF and investigator assessment following the completion of study treatment for responders.
Time frame: Up to approximately 7 months
1-Year PFS Rate by IRF and Investigator Assessment per 2014 Lugano Classification
The 1-year PFS rate by IRF and investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time frame: Up to approximately 12 months
Duration of Response (DOR) by Investigator Assessment per 2014 Lugano Classification
DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time frame: Up to approximately 36 months
Serum Antibody-drug Conjugate (ADC) Concentration
Time frame: Preinfusion and at multiple time points (Up to 96 hours [Cycle 1]/168 hours [Cycle 2]) postinfusion; Preinfusion up to Cycle 8, each cycle = 21 days
Plasma Monomethyl Auristatin E (MMAE) Concentration
Time frame: Preinfusion and at multiple time points (Up to 96 hours [Cycle 1]/168 hours [Cycle 2]) postinfusion; Preinfusion up to Cycle 8, each cycle = 21 days
Percentage of Participants who are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive, ADA Titer, and Neutralizing Antidrug Antibody (Nab) Negative and Positive
Time frame: Preinfusion on Day 1 of each cycle up to Cycle 8, each cycle = 21 days