Extranodal Natural Killer/T-Cell Lymphoma Clinical Trial
Official title:
A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
| Verified date | May 2024 |
| Source | CStone Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | March 20, 2023 |
| Est. primary completion date | March 20, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: 1. Subject must have a histologically confirmed NKTL at study site. 2. Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification. 5. Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency. 6. Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review. 7. Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or = Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Exclusion Criteria: 1. Invasive natural killer leukemia. 2. Concomitant with hemophagocytic syndrome. 3. Primary site in central nervous system (CNS) or CNS involvement. 4. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001. 5. Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001. 6. Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001. 7. Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001. 8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome. 9. Subjects with active hepatitis B or C infection. 10. Subjects with active tuberculosis infection. 11. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody. 12. Female subjects who are pregnant or breast-feeding. For more information regarding trial participation, please contact at cstonera@cstonepharma.com |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University Third Hospital | Beijing | |
| China | Hunan Cancer Hospital | Changsha | |
| China | West China Hospital of Sichuan University | Chengdu | |
| China | Fujian Cancer Hospital | Fuzhou | |
| China | Sun Yat-sen University Cancer Prevention Center | Guangzhou | |
| China | Guizhou Cancer Hospital | Guiyang | |
| China | The First Affiliated Hospital of Zhejiang University | Hangzhou | |
| China | Zhejiang Cancer Hospital | Hangzhou | |
| China | Anhui Cancer Hospital | Hefei | |
| China | Cancer Hospital Affiliated to Guangxi Medical University | Nanning | |
| China | Fudan University Shanghai Cancer Hospital | Shanghai | |
| China | Shanghai East Hospital | Shanghai | |
| China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | |
| China | Liaoning Cancer Hospital | Shenyang | |
| China | Tianjin Cancer Hospital | Tianjin | |
| China | Cancer Center of Union Hospital, Huazhong University of Science and Technology | Wuhan | |
| China | Henan Cancer Hospital | Zhengzhou |
| Lead Sponsor | Collaborator |
|---|---|
| CStone Pharmaceuticals |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 6-months Progression-free Survival (PFS) Rate Assessed by Investigators | 6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | 6 months | |
| Other | 6-months PFS Rate Assessed by IRRC | 6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | 6 months | |
| Other | 6-month Overall Survival (OS) Rate | 6 months | ||
| Primary | Objective Response Rate (ORR) Assessed by IRRC | ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Objective Response Rate (ORR) Assessed by Investigators | ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Complete Response Rate (CRR) by Investigators | CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Complete Response Rate (CRR) Assessed by IRRC | CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Partial Response Rate (PRR) Assessed by Investigators | PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Partial Response Rate (PRR) Assessed by IRRC | PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Duration of Response (DoR) Assessed by Investigators | DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Duration of Response (DoR) Assessed by IRRC | DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Time to Response (TTR) Assessed by Investigators | TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Time to Response (TTR) Assessed by IRRC | TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months | |
| Secondary | Number of Participants With Adverse Events | From enrollment to end of follow-up, a median of 29 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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