Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study
NCT04296786 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2020-03-05
Summary
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Conditions
- Cutaneous T-cell Lymphoma
Interventions
- DRUG
-
Sintilimab
200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment
- DRUG
-
Chidamide
20mg po per week continuously
Sponsors & Collaborators
-
Peking University Third Hospital
collaborator OTHER -
Beijing Longfu Hospital
collaborator UNKNOWN -
Dongzhimen Hospital, Beijing
collaborator OTHER -
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-01
- Primary Completion
- 2022-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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