Trials / Active Not Recruiting
Active Not RecruitingNCT04624958
Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL
Zanubrutinib and Rituximab Followed by R-DHAOx (Rituximab, Dexamethasone, Cytarabine and Oxaliplatin) Regimen Then Maintenance with Zanubrutinib for Newly-Diagnosed Mantle Cell Lymphoma (MCL): a Single Arm, Open Label, Multi-center Phase II Study
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib and Rituximab | Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1. |
| DRUG | R-DHAOx | Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1. |
| DRUG | Zanubrutinib Maintenance | Zanubrutinb 160mg PO BID. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2024-12-01
- Completion
- 2026-12-01
- First posted
- 2020-11-12
- Last updated
- 2024-10-18
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04624958. Inclusion in this directory is not an endorsement.