A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

CStone Pharmaceuticals17 sites in 1 country80 target enrollmentJune 12, 2018

ConditionsExtranodal Natural Killer/T-Cell Lymphoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Extranodal Natural Killer/T-Cell Lymphoma
Sponsor: CStone Pharmaceuticals
Enrollment: 80
Locations: 17
Primary Endpoint: Objective Response Rate (ORR) Assessed by IRRC
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death.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.

Registry

clinicaltrials.gov

Start Date

June 12, 2018

End Date

March 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CStone Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must have a histologically confirmed NKTL at study site.
•Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
•Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
•Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
•Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
•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

•Invasive natural killer leukemia.
•Concomitant with hemophagocytic syndrome.
•Primary site in central nervous system (CNS) or CNS involvement.
•Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS
•Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS
•Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS
•Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS
•Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
•Subjects with active hepatitis B or C infection.
•Subjects with active tuberculosis infection.

Outcomes

Primary Outcomes

Objective Response Rate (ORR) Assessed by IRRC

Time Frame: From enrollment to end of follow-up, a median of 29 months

ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Secondary Outcomes

Time to Response (TTR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
Complete Response Rate (CRR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
Duration of Response (DoR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
Objective Response Rate (ORR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
Partial Response Rate (PRR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
Partial Response Rate (PRR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
Complete Response Rate (CRR) by Investigators(From enrollment to end of follow-up, a median of 29 months)
Time to Response (TTR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
Duration of Response (DoR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
Number of Participants With Adverse Events(From enrollment to end of follow-up, a median of 29 months)