Trials / Completed
CompletedNCT03505996
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- CStone Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CS1001 | Monoclonal antibody |
Timeline
- Start date
- 2018-05-22
- Primary completion
- 2020-02-19
- Completion
- 2021-11-01
- First posted
- 2018-04-23
- Last updated
- 2022-10-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03505996. Inclusion in this directory is not an endorsement.