Trials / Unknown
UnknownNCT04058470
Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma
Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Huiqiang Huang · Academic / Other
- Sex
- All
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
1. Phase I portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab in treating untreated elderly diffuse large B cell lymphoma patients. 2. The aim of phase II portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab followed by R-CHOP(rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) regimen in treating untreated elderly diffuse large B cell lymphoma patients.
Detailed description
The study consisted of a phase I and II portion. In phase I, patients accepted at least 2 cycles of toripalimab plus rituximab. Another 2 cycles of toripalimab plus rituximab will offered if they achieved CR. In phase II, all patients accpet R-CHOP regimen. If patient get CR after, they will accept 4 cycles of R-CHOP regimen, patients with PR,SD or PD will accept 6 cycles of R-CHOP.
Conditions
- Diffuse Large B Cell Lymphoma
- High-grade B-cell Lymphoma
- Follicular Lymphoma Grade IIIb
- Transformed Lymphoma
- EBV-Positive DLBCL, Nos
- ALK-Positive Anaplastic Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Toripalimab, Rituximab | Toripalimab in combination with Rituximab will be administered every 3 weeks up to 4 cycles. |
| DRUG | R-CHOP Protocol | After toripalimab plus rituximab treatment, R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP up to 6 cycles. |
Timeline
- Start date
- 2020-04-24
- Primary completion
- 2023-12-30
- Completion
- 2025-12-30
- First posted
- 2019-08-15
- Last updated
- 2022-04-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04058470. Inclusion in this directory is not an endorsement.