A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hodgkin Lymphoma
- Sponsor
- CStone Pharmaceuticals
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)
Detailed Description
Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with histologically confirmed cHL at study site.
- •Relapsed or refractory cHL that failed at least two lines of systemic therapy.
- •ECOG PS of 0-
- •Subjects with at least one measurable lesion at baseline.
- •Subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =\< Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
- •Subjects who agree to use highly effective contraception.
Exclusion Criteria
- •Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.
- •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 had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS
- •Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS
- •Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS
- •Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
- •Subjects with active Hepatitis B or C infection.
- •Subjects with active tuberculosis infection.
- •Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti CTLA-4 monoclonal antibody.
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: From first patient first visit to 6 month after last patient first visit
The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification