Trials / Unknown
UnknownNCT03853044
Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chidamide | Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles |
| DRUG | Cyclophosphamide | 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 | Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle. |
Timeline
- Start date
- 2018-12-29
- Primary completion
- 2021-06-30
- Completion
- 2022-12-01
- First posted
- 2019-02-25
- Last updated
- 2022-04-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03853044. Inclusion in this directory is not an endorsement.