The main aim is to check the long-term side effects of treatment with Brentuximab Vedotin and to see if that treatment improves symptoms of cluster of differentiation antigen 30 (CD30-Positive) Cutaneous T-Cell Lymphoma in Chinese adults. Participants will receive brentuximab vedotin through the vein on day 1 of each 21 day cycle up to maximum 16 cycles.
The drug being tested in this study is called brentuximab vedotin (SGN-35). Brentuximab vedotin is being tested to treat people who have CD30-positive cutaneous T-Cell lymphoma. The study will enroll approximately 10 patients. Participants will receive a single treatment i.e., brentuximab vedotin monotherapy: • Brentuximab vedotin 1.8 mg/kg Participants will be administered with brentuximab vedotin by intravenous (IV) infusion given for approximately 30 minutes on Day 1 of each 21-day cycle up to 16 cycles followed by the end of treatment (EOT) visit 30 days after receiving the final dose of study drug. Participants with progressive disease (PD) at any time during the study will be discontinued from study drug. This multi-center trial will be conducted in China. Participants will remain in this study for approximately 56 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Brentuximab vedotin IV infusion.
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that lasts at least 4 months. CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral involvement using computed tomography (CT) scan, and for the participants with mycosis fungoides (MF) only, detection of circulating Sezary cells. Response Criteria were based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines.
Time frame: Up to 58 weeks
Complete Response (CR) Rate
CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using computed tomography (CT) scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines.
Time frame: Up to 58 weeks
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using CT scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines.
Time frame: Up to 58 weeks
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Duration of Response (DOR)
Duration of response was assessed in participants with CR or PR and is defined as the time between first documentation of response and progressive disease (PD). Response criteria were based on ISCL, USCLC and EORTC Consensus guidelines. Participants who were lost to follow-up, withdrew consent, or discontinued treatment due to undocumented PD after the last adequate disease assessment were censored at the last disease assessment.
Time frame: Up to 58 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; 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. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE and SAE were determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: From first dose of study drug through 30 days after the last dose of study drug (up to approximately 58 weeks)
Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure
Vital signs included seated blood pressure (systolic and diastolic) measurements.
Time frame: Baseline, at end of treatment (approximately Week 54)
Changes From Baseline in Participant's Vital Sign: Heart Rate
Vital signs included heart rate (beats per minute) measurements.
Time frame: Baseline, at end of treatment (approximately Week 54)
Changes From Baseline in Participant's Vital Sign: Body Temperature
Vital signs included body temperature (degree Celsius) measurements.
Time frame: Baseline, at end of treatment (approximately Week 54)
Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
ECOG scale was used to assess performance status of participants. Grades range from 0 (fully active) to 5 (dead) where Grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed \<50% of the time. Grade 3: In bed \>50% of the time. Grade 4: 100% bedridden. Grade 5: Dead. Lower grades indicate improvement. Reported here is the number of participants in each reported baseline grade to their worst post-baseline grade assessment on the ECOG scale.
Time frame: Baseline up to 30 days after the last dose of study drug (up to approximately 58 weeks)
Change From Baseline in Hematology Parameter: Hemoglobin
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Hematology Parameter: Neutrophil Count
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Hematology Parameter: Platelet Count
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Hematology Parameter: Lymphocyte Count
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Hematology Parameter: Leukocyte Count
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Total Bilirubin
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Lipase
Time frame: Baseline, at end of treatment (approximately Week 54)
Change From Baseline in Serum Chemistry Parameter: Amylase
Time frame: Baseline, at end of treatment (approximately Week 54)