| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type Early Stage Anlotinib Peg-aspargase Sintilimab Phase Two Open | Drug: Sintilimab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open, Multi-center, Phase II Study of Sintilimab, Peg-aspargase Plus Anlotinib in Previously Untreated Stage I-II Extranodal NK/T Cell Lymphoma |
| Actual Study Start Date : | April 28, 2019 |
| Estimated Primary Completion Date : | April 30, 2020 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment arm
Sintilimab 200mg ivdrip D1 Peg-aspargase 2500U/m2 im D1 Anlotinib 12 mg po D1-14 repeat every three weeks
|
Drug: Sintilimab
Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy
Other Names:
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Zhiming Li, Dr. | +86-020-87343765 | lizhm@sysucc.org.cn | |
| Contact: Peng Sun, Dr. | +86-020-87343363 | sunp@sysucc.org.cn |
| China, Guangdong | |
| Sun Yat-Sen University Cancer Center | Recruiting |
| Guandong, Guangdong, China, 510060 | |
| Contact: Zhiming Li, Dr. +86-020-87343765 lizhm@sysucc.org.cn | |
| China, Guangxi | |
| Guangxi Medicanl Universitu Affiliated Tumor Hospital | Recruiting |
| Nanning, Guangxi, China, 530000 | |
| Principal Investigator: Hong Ceng | |
| The First Affiliated Hospital of Guangxi Medical University | Recruiting |
| Nanning, Guangxi, China, 530000 | |
| Principal Investigator: Jie Ma | |
| China, Hunan | |
| Hunan Cancer Hospital | Recruiting |
| Changsha, Hunan, China, 410000 | |
| Principal Investigator: Hui Zhou | |
| China, Sichuan | |
| West China Hospital.Sichuan University | Recruiting |
| Chengdu, Sichuan, China, 610000 | |
| Principal Investigator: Liqun Zou | |
| China, Yunnan | |
| Yunan Cancer Hospital | Recruiting |
| Kunming, Yunnan, China, 650000 | |
| Principal Investigator: Chunlin Gao | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||||||
| First Posted Date ICMJE | May 3, 2019 | ||||||||
| Last Update Posted Date | September 27, 2019 | ||||||||
| Actual Study Start Date ICMJE | April 28, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| 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 | Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T Cell Lymphoma | ||||||||
| Official Title ICMJE | An Open, Multi-center, Phase II Study of Sintilimab, Peg-aspargase Plus Anlotinib in Previously Untreated Stage I-II Extranodal NK/T Cell Lymphoma | ||||||||
| Brief Summary | This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, combined with radiotherapy. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities. | ||||||||
| Detailed Description | Not Provided | ||||||||
| 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 |
|
||||||||
| Intervention ICMJE | Drug: Sintilimab
Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy
Other Names:
|
||||||||
| Study Arms ICMJE | Experimental: Treatment arm
Sintilimab 200mg ivdrip D1 Peg-aspargase 2500U/m2 im D1 Anlotinib 12 mg po D1-14 repeat every three weeks
Intervention: Drug: Sintilimab
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||||
| Estimated Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03936452 | ||||||||
| Other Study ID Numbers ICMJE | B2019-048-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Li Zhiming, Sun Yat-sen University | ||||||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Sun Yat-sen University | ||||||||
| Verification Date | September 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||