Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-010 | Experimental | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle | Drug | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS is defined as the duration from start of selinexor treatment to time of central imaging laboratory determined PD (based on 2014 Lugano criteria: Progressive metabolic disease requires Score 4 or 5 with an increase in intensity of uptake from baseline. Progressive disease by CT criteria only requires an increase in the PPDs of a single node by ≥ 50%.)or death from any cause, whichever occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bingshan Liu, MD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Cancer Hospital | Hefei | Anhui | 230000 | China | ||
| Beijing Cancer Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ATG-010 | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010. ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12 months |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Chongqing Universtity Cancer Hospital | Chongqing | Chongqing Municipality | 400000 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430000 | China |
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Affilate Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116027 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin blood research institute | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Cancer Hospital of the University of the Chinese Academy of Sciences | Hangzhou | Zhejiang | 310022 | China |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ATG-010 | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010. ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. |
| 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | ORR | ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.) | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | PFS | PFS is defined as the duration from start of selinexor treatment to time of central imaging laboratory determined PD (based on 2014 Lugano criteria: Progressive metabolic disease requires Score 4 or 5 with an increase in intensity of uptake from baseline. Progressive disease by CT criteria only requires an increase in the PPDs of a single node by ≥ 50%.)or death from any cause, whichever occurs first. | Posted | Median | 95% Confidence Interval | month | 12 months |
|
|
From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
Not provided
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 | ATG-010 | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010. ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. | 43 | 60 | 24 | 60 | 60 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count dicreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Adynamia | General disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Cause Death | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Spinal cord compression | Nervous system disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Appetite decreased | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Adynamia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yumei Tang | Antengene Corporation | 18301318100 | yumei.tang@antengene.com |
| Apr 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-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 |
|---|---|
| C585161 | selinexor |
Not provided
Not provided
Not provided
|