Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
NCT03853044 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2022-04-20
Summary
This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.
Conditions
- Angioimmunoblastic T-cell Lymphoma
Interventions
- DRUG
-
Chidamide
Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
- DRUG
-
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
- DRUG
-
Doxorubicin
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
- DRUG
-
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
- DRUG
-
Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Principal Investigators
-
Weili Zhao, MD. PhD · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-29
- Primary Completion
- 2021-06-30
- Completion
- 2022-12-31
Countries
- China
Study Locations
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