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Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR2554 monotherapy | Experimental | Patients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 Tablets | Drug | SHR2554 orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 years PFS | The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year and 2-year DFS rates for patients who were in CR at enrollment | The rate of 1-year and 2-year that the participant lives without disease, as assessed by 2014 Lugano criteria. | 1year,2year |
| Rate of patients who were PR at enrollment converting to CR |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD)-Negative Rate | The proportion of patients who achieve minimal residual disease negativity at the completion of treatment. | Up to 12 months after the first dose |
Inclusion Criteria:
Exclusion Criteria:
1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and/or uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xu, Doctor | Contact | 86-2568302182 | xuwei10000@hotmail.com | |
| Jinhua Liang, M.D | Contact | 86-2568302182 | 1151525490@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
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The Rate of patients who were PR at enrollment converting to CR |
| Time from the first dose to any events, assessed up to 12 months |
| Complete Response Rate (CR) | The proportion of participants who achieve a complete response (CR) during the treatment period, as assessed by the 2014 Lugano criteria using FDG-PET imaging. | Time from the first dose to disease progression or death, assessed up to 12months |
| Duration of Response (DoR) | The interval from the initial documentation of response (CR or PR) to the first documentation of disease progression or death. | From the date response is first documented to the date of disease progression or death, up to 36 months |
| Progression-Free Survival (PFS) | The length of time during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria. | Time from the first dose to disease progression or death, assessed up to 36 months |
| Overall Survival (OS) | The length of time from the start of treatment until death from any cause. | Time from the first dose to death from any cause, assessed up to 36 months |
| Incidence of Treatment-Related Adverse Events (Safety and Tolerability) | The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment. | Up to 12 months |