Trials / Unknown
UnknownNCT03213977
R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With High-risk DLBCL
A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT，in Newly Diagnosed Young Patients With High-risk DLBCL
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 475 (estimated)
- Sponsor
- Fujian Medical University · Academic / Other
- Sex
- All
- Age
- 16 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Patients initially are randomized into 2 arms: Arm I: R-DA-EPOCH; Arm II: R-CEOP90; Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
Detailed description
Patients initially are randomized into 2 arms: Arm I: R-DA-EPOCH; Arm II: R-CEOP90; Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols. The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has similar efficacy compared to that with R-DA-EPOCH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | R-DA-EPOCH | R-DA-EPOCH-21 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy. |
| DRUG | R-CEOP90 | R-CEOP90 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy. |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2023-07-13
- Completion
- 2024-07-13
- First posted
- 2017-07-11
- Last updated
- 2024-03-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03213977. Inclusion in this directory is not an endorsement.