Back to resultsA Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma
Primary Purpose
T-Cell Lymphoma
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Brentuximab vedotin
Sponsored by
About this trial
This is an interventional treatment trial for T-Cell Lymphoma focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
1. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+) disease by local laboratory assessment and pathology review.
2. Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who have received prior radiation therapy or at least 1 prior systemic therapy, or participants with mycosis fungoides (MF) who have received at least 1 prior systemic therapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 4. Suitable venous access for the study-required blood sampling. 5. Participants must have radiographically or clinically measurable or evaluable disease.
6. Recovered (i.e., Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy.
-Exclusion Criteria:
- A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or other non-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).
- A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2) disease.
- Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
- Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
- Life-threatening illness unrelated to cancer.
- Severe central nervous system (CNS), pulmonary, renal, or hepatic disease not related to the participant's cancer.
- Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
- Any severe active systemic viral, bacterial, or fungal infection within 1 week before first study drug dose requiring systemic antimicrobial therapy. (Oral antibiotics for prophylaxis are allowed.)
- Receiving antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
- Myocardial infarction within 6 months of enrollment.
- New York Heart Association (NYHA) Class III or IV heart failure.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- History of another primary malignancy not in remission for at least 3 years. The following are exempt from the 3-year limit: completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear.
- Oral retinoid therapy for any indication within 3 weeks of the first dose of study drug.
- History of pancreatitis or significant risk factors for developing pancreatitis (eg, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
Sites / Locations
- Peking University First Hospital
- Peking University Third Hospital
- Huashan Hospital, Fudan University
- West China Hospital, Sichuan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brentuximab Vedotin 1.8 mg/kg
Arm Description
Brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Outcomes
Primary Outcome Measures
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 will be 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 circulation Sezary cells. Response Criteria will be 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 (Olsen, 2011).
Secondary Outcome Measures
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 will be 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 circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
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 will be 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 circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
Duration of Response (DOR)
Duration of response will be assessed in participants with CR or PR and is defined as the time between first documentation of response and PD. Response criteria will be based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
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 (eg, 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 will be determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Changes from Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure
Vital signs will include seated blood pressure (systolic and diastolic) measurements.
Changes from Baseline in Participant's Vital Sign: Heart Rate
Vital signs will include heart rate (beats per minute) measurements.
Changes from Baseline in Participant's Vital Sign: Body Temperature
Vital signs will include body temperature (degree celsius) measurements.
Change From Baseline in Participant's Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
ECOG scale will be 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.
Change from Baseline in Hematology Parameter: Hemoglobin
Change from Baseline in Hematology Parameter: Leukocyte with Differential Absolute Neutrophil Count (ANC)
Change from Baseline in Hematology Parameter: Platelet Count
Change from Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)
Change from Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)
Change from Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)
Change from Baseline in Serum Chemistry Parameter: Total Bilirubin
Change from Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen (BUN)
Change from Baseline in Serum Chemistry Parameter: Calcium
Change from Baseline in Serum Chemistry Parameter: Creatinine
Change from Baseline in Serum Chemistry Parameter: Lipase
Change from Baseline in Serum Chemistry Parameter: Chloride
Change from Baseline in Serum Chemistry Parameter: Gamma Glutamyl Transferase (GGT)
Change from Baseline in Serum Chemistry Parameter: Glucose
Change from Baseline in Serum Chemistry Parameter: Magnesium
Change from Baseline in Serum Chemistry Parameter: Phosphate
Change from Baseline in Serum Chemistry Parameter: Potassium
Change from Baseline in Serum Chemistry Parameter: Sodium
Change from Baseline in Serum Chemistry Parameter: Amylase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442554
Brief Title
A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma
Official Title
A Phase 4, Single Arm, Open Label, Multicenter Study of Brentuximab Vedotin Treatment of Chinese Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Cell Lymphoma
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brentuximab Vedotin 1.8 mg/kg
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Intervention Type
Drug
Intervention Name(s)
Brentuximab vedotin
Other Intervention Name(s)
SGN-35
Intervention Description
Brentuximab vedotin IV infusion.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL
Description
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 will be 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 circulation Sezary cells. Response Criteria will be 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 (Olsen, 2011).
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Complete Response (CR) Rate
Description
CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR will be 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 circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
Time Frame
Up to 48 weeks
Title
Overall Response Rate (ORR)
Description
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 will be 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 circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
Time Frame
Up to 48 weeks
Title
Duration of Response (DOR)
Description
Duration of response will be assessed in participants with CR or PR and is defined as the time between first documentation of response and PD. Response criteria will be based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).
Time Frame
Up to 48 weeks
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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 (eg, 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 will be 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 48 weeks)
Title
Changes from Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure
Description
Vital signs will include seated blood pressure (systolic and diastolic) measurements.
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Changes from Baseline in Participant's Vital Sign: Heart Rate
Description
Vital signs will include heart rate (beats per minute) measurements.
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Changes from Baseline in Participant's Vital Sign: Body Temperature
Description
Vital signs will include body temperature (degree celsius) measurements.
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change From Baseline in Participant's Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Description
ECOG scale will be 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.
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Hematology Parameter: Hemoglobin
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Hematology Parameter: Leukocyte with Differential Absolute Neutrophil Count (ANC)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Hematology Parameter: Platelet Count
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Total Bilirubin
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen (BUN)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Calcium
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Creatinine
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Lipase
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Chloride
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Gamma Glutamyl Transferase (GGT)
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Glucose
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Magnesium
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Phosphate
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Potassium
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Sodium
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Title
Change from Baseline in Serum Chemistry Parameter: Amylase
Time Frame
Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+) disease by local laboratory assessment and pathology review.
2. Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who have received prior radiation therapy or at least 1 prior systemic therapy, or participants with mycosis fungoides (MF) who have received at least 1 prior systemic therapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 4. Suitable venous access for the study-required blood sampling. 5. Participants must have radiographically or clinically measurable or evaluable disease.
6. Recovered (i.e., Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy.
-Exclusion Criteria:
A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or other non-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).
A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2) disease.
Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
Life-threatening illness unrelated to cancer.
Severe central nervous system (CNS), pulmonary, renal, or hepatic disease not related to the participant's cancer.
Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
Any severe active systemic viral, bacterial, or fungal infection within 1 week before first study drug dose requiring systemic antimicrobial therapy. (Oral antibiotics for prophylaxis are allowed.)
Receiving antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
Myocardial infarction within 6 months of enrollment.
New York Heart Association (NYHA) Class III or IV heart failure.
Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
History of another primary malignancy not in remission for at least 3 years. The following are exempt from the 3-year limit: completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear.
Oral retinoid therapy for any indication within 3 weeks of the first dose of study drug.
History of pancreatitis or significant risk factors for developing pancreatitis (eg, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/52b934f938554c0e?idFilter=%5B%22VedolizumabSC-4003%22%5D
Description
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Learn more about this trial
A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma
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