Clinical trial NCT03595657: A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extranodal Natural Killer/T-Cell Lymphoma
Keywords: ENKTL
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR) Assessed by IRRC
timeFrame: From enrollment to end of follow-up, a median of 29 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Assessed by Investigators
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Complete Response Rate (CRR) by Investigators
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Complete Response Rate (CRR) Assessed by IRRC
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Partial Response Rate (PRR) Assessed by Investigators
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Partial Response Rate (PRR) Assessed by IRRC
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Duration of Response (DoR) Assessed by Investigators
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Duration of Response (DoR) Assessed by IRRC
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Time to Response (TTR) Assessed by Investigators
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Time to Response (TTR) Assessed by IRRC
timeFrame: From enrollment to end of follow-up, a median of 29 months
measure: Number of Participants With Adverse Events
timeFrame: From enrollment to end of follow-up, a median of 29 months
Other outcomes:
measure: 6-months Progression-free Survival (PFS) Rate Assessed by Investigators
timeFrame: 6 months
measure: 6-months PFS Rate Assessed by IRRC
timeFrame: 6 months
measure: 6-month Overall Survival (OS) Rate
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Prevention Center
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Cancer Hospital
city: Nanning
country: China
facility: Cancer Hospital Affiliated to Guangxi Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Cancer Center of Union Hospital, Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: