Extranodal Natural Killer/T-cell Lymphoma Clinical Trial
Official title:
Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E
| Status | Not yet recruiting |
| Enrollment | 72 |
| Est. completion date | June 1, 2028 |
| Est. primary completion date | June 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria - Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol Exclusion Criteria: - The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Nanjing Medical University | Nanjing |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Changzhou First People's Hospital, Changzhou Second People's Hospital, Huaian first people's hospital, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Nantong University, Wuxi People's Hospital, Yancheng First People's Hospital, Zhenjiang First People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL | 2 years | ||
| Secondary | To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients | 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03595657 -
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
|
Phase 2 |