| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| CD20 Positive B Cell NHL | Drug: 304 injection Drug: rituximab injection | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Study of Pharmacokinetics, Efficacy, and Safety of 304 Injection Compared With Rituximab in B Cell Non-Hodgkin's Lymphoma |
| Actual Study Start Date : | December 18, 2018 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | October 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: experimental group
304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL
|
Drug: 304 injection
Monoclonal antibodies, 100mg/10ml per injection
|
|
Active Comparator: control group
Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.
|
Drug: rituximab injection
100mg/10ml per injection ,manufactured by Roche
|
To assess PK parameter of plasma 304 or rituximab:
Area under the concentration-time curve from time zero extrapolated to infinity (AUC [0-∞])
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Gang Tong | +86- 21- 84892211 | tonggang@3sbio.com |
| China, Beijing | |
| The 307 Hospital of People's Liberation Army | Recruiting |
| Beijing, Beijing, China, 100071 | |
| Contact: Hang Su 13701396736 suhang307@126.com | |
| Principal Investigator: hang Su | |
| Beijing Luhe Hospital Capital Medical University | Recruiting |
| Beijing, Beijing, China, 101100 | |
| Contact: dong Yan 13621308215 yd15yt88@163.com | |
| Principal Investigator: dong Yan | |
| China, Guangdong | |
| Sun Yat-Sen University Cancer Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510600 | |
| Contact: huiqiang huang 020-87343535 huanghq@sysucc.org.cn | |
| Principal Investigator: huiqiang huang | |
| China, Hebei | |
| The Fourth Hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China, 050010 | |
| Contact: Lihong Liu 13831177920; 13831177920@163.com | |
| Principal Investigator: Lihong Liu | |
| China, Heibei | |
| Affiliated Hospital of Hebei University | Recruiting |
| Baoding, Heibei, China, 071000 | |
| Contact: aimin Zang 03125983056 hdfygcp@163.com | |
| Principal Investigator: aimin Zang | |
| China, Henan | |
| Zhengzhou Central Hospital | Recruiting |
| Zhengzhou, Henan, China, 450007 | |
| Contact: shanyong Yi 15516991321 yisy2001@126.com | |
| Principal Investigator: shanyong Yi | |
| The First Affiliated Hospita of Zhengzhou University | Recruiting |
| Zhengzhou, Henan, China, 450052 | |
| Contact: mingzhi Zhang 13838565629 mingzhi_zhang@126.com | |
| Principal Investigator: mingzhi Zhang | |
| China, Shandong | |
| Weihai Municipal Hospital | Recruiting |
| Weihai, Shandong, China, 264200 | |
| Contact: xiuzhi Deng 18660377358 18660377358@126.com | |
| Principal Investigator: xiuzhi Deng | |
| China, Tianjing | |
| Tianjin Medical University Cancer Institute &Hospital | Recruiting |
| Tianjing, Tianjing, China, 300060 | |
| Contact: Lanfang Li 18622221613 Lilanfangmeng@163.com | |
| Principal Investigator: Lanfang Li | |
| China, Zhejiang | |
| The Second Affiliated Hospital of Soochow University | Recruiting |
| Suzhou, Zhejiang, China, 215000 | |
| Contact: zhixiang Zhuang 13951106391 13951106391@139.com | |
| Principal Investigator: zhixiang Zhuang | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 6, 2019 | ||||
| First Posted Date ICMJE | June 10, 2019 | ||||
| Last Update Posted Date | June 10, 2019 | ||||
| Actual Study Start Date ICMJE | December 18, 2018 | ||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetics, Efficacy and Safety of the 304 Injection | ||||
| Official Title ICMJE | A Study of Pharmacokinetics, Efficacy, and Safety of 304 Injection Compared With Rituximab in B Cell Non-Hodgkin's Lymphoma | ||||
| Brief Summary | The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection. | ||||
| Detailed Description | This is a multi-center, randomized, double-blind, parallel controlled, single-dose study to evaluate the pharmacokinetic, safety and efficacy of 304 injection compared with rituximab injection. To avoid the impact of tumor burden on pharmacokinetics, this study will be conducted in CD20 positive B-cell non-Hodgkin lymphoma patients who have achieved CR/CRu status and have not yet deteriorated or relapsed. All patients will be randomly averagely entered into the experimental group and the control group. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | CD20 Positive B Cell NHL | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* 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 | Unknown status | ||||
| Estimated Enrollment ICMJE |
60 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | October 31, 2019 | ||||
| Estimated Primary Completion Date | June 30, 2019 (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 to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03980379 | ||||
| Other Study ID Numbers ICMJE | SSGJ-304-NHL-I-02 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
| Study Sponsor ICMJE | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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