Trials / Recruiting
RecruitingNCT05933967
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Shandong Cancer Hospital and Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
Detailed description
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orelabrutinib+R-CHOP | Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2024-12-30
- Completion
- 2026-12-30
- First posted
- 2023-07-06
- Last updated
- 2023-08-15
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05933967. Inclusion in this directory is not an endorsement.