Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
Actual Study Start Date : | April 9, 2020 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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Experimental: ATG-010
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
|
Drug: 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.
Other Name: Selinexor
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Unstable cardiovascular function:
Contact: Jasmine Sun, MD | 13701803117 | jasmine.sun@antengene.com | |
Contact: Stacey Chen, MD | stacey.chen@antengene.com |
China, Beijing | |
Beijing Cancer Hospital | Recruiting |
Beijing, Beijing, China, 100142 | |
Contact: Yuqin Song, PhD | |
Principal Investigator: Yuqin Song, PhD | |
Peking University Third Hospital | Recruiting |
Beijing, Beijing, China, 100191 | |
Contact: Hongmei Jing, PhD | |
Principal Investigator: Hongmei Jing, PhD | |
China, Guangdong | |
Sun Yat-Sen University Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Qingqing Cai, PhD | |
Principal Investigator: Qingqing Cai, PhD | |
China, Heilongjiang | |
Harbin Medical University Cancer Hospital | Recruiting |
Harbin, Heilongjiang, China, 150081 | |
Contact: Qingyuan Zhang, PhD | |
Principal Investigator: Qingyuan Zhang, PhD | |
China, Henan | |
Henan Cancer Hospital | Recruiting |
Zhengzhou, Henan, China, 450003 | |
Contact: Yongping Song, PhD | |
Principal Investigator: Yongping Song, PhD | |
China, Hubei | |
Wuhan Union Hospital | Recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Liling Zhang, PhD | |
Principal Investigator: Liling Zhang, PhD | |
China, Hunan | |
Hunan Cancer Hospital | Not yet recruiting |
Changsha, Hunan, China, 410013 | |
Contact: Hui Zhou, PhD | |
Principal Investigator: Hui Zhou, PhD | |
China, Jiangsu | |
The First Affilate Hospital with Nanjing Medical University | Not yet recruiting |
Nanjing, Jiangsu, China, 210029 | |
Contact: Huayuan Zhu, PhD | |
Principal Investigator: Huayuan Zhu, PhD | |
China, Jilin | |
The First Bethune Hospital of Jilin University | Not yet recruiting |
Chang chun, Jilin, China, 130021 | |
Contact: Sujun Gao, PhD | |
Principal Investigator: Sujun Gao, PhD | |
China, Liaoning | |
The Second Hospital of Dalian Medical University | Recruiting |
Dalian, Liaoning, China, 116027 | |
Contact: Yang Zhang, PhD | |
Principal Investigator: Yang Zhang, PhD | |
China, Shanghai | |
Fudan University Shanghai Cancer Center | Not yet recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Junning Cao, PhD | |
Principal Investigator: Junning Cao, PhD | |
China, Sichuan | |
West China Hospital of Sichuan University | Recruiting |
Chengdu, Sichuan, China, 610041 | |
Contact: Liqun Zou, PhD | |
Principal Investigator: Liqun Zou, PhD | |
China, Tianjin | |
Tianjin blood research institute | Not yet recruiting |
Tianjin, Tianjin, China, 300052 | |
Contact: Tingyu Wang, PhD | |
Principal Investigator: Tingyu Wang, PhD | |
Tianjin Medical University Cancer Institute & Hospital | Recruiting |
Tianjin, Tianjin, China, 300060 | |
Contact: Lanfang Li, PhD | |
Principal Investigator: Lanfang Li, PhD | |
China, Zhejiang | |
Cancer Hospital of the University of the Chinese Academy of Sciences | Recruiting |
Hangzhou, Zhejiang, China, 310022 | |
Contact: Haiyan Yang, PhD | |
Principal Investigator: Haiyan Yang, PhD |
Study Director: | shan bing, MD | Medical Monitor |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 18, 2019 | ||||||||
First Posted Date ICMJE | June 20, 2019 | ||||||||
Last Update Posted Date | May 28, 2021 | ||||||||
Actual Study Start Date ICMJE | April 9, 2020 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
ORR [ Time Frame: 18 months ] Percentage of subjects with PR, or CR
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Original Primary Outcome Measures ICMJE |
ORR [ Time Frame: 18 months ] To evaluate the efficacy of ATG-010 in level of overall response rate (ORR) with relapsed/refractory DLBCL patients who have at least 2 but no more than 5 previous systemic regimens
|
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma | ||||||||
Official Title ICMJE | An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | ||||||||
Brief Summary | This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma. | ||||||||
Detailed Description | 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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | ||||||||
Intervention ICMJE | Drug: 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.
Other Name: Selinexor
|
||||||||
Study Arms ICMJE | Experimental: ATG-010
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
Intervention: Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle
|
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03992339 | ||||||||
Other Study ID Numbers ICMJE | ATG-010-DLBCL-001 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Antengene Corporation | ||||||||
Study Sponsor ICMJE | Antengene Corporation | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Antengene Corporation | ||||||||
Verification Date | May 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |