Clinical trial · Interventional
The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.
NCT05428670CI-TRIAL-00059268unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RCHOP/RCDOP | Drug | — | UNRESOLVED |
| Zanubrutinib+Rituximab+Lenalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zanubrutinib+Rituximab+Lenalidomide
- description
- The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Zanubrutinib, 160 mg bid, po, day 2-21; Lenalidomide, 10-20 mg qd, po, day 2-14; Rituximab, 375 mg/m², ivgtt, day 1. Maintenance therapy: Patients who receive complete response or partial response after induction therapy will receive lenalidomide 10-20 mg qd po during 1-21 days in every 28 days, for a maximum of 2 years.
- interventionNames
- Drug: Zanubrutinib+Rituximab+Lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- RCHOP/RCDOP
- description
- The RCHOP/RCDOP regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Rituximab, 375 mg/m², ivgtt, day 1; Cyclophosphamide, 500-750 mg/m², ivgtt, day 2; Doxorubicin, 50 mg/m², ivgtt day 2 (liposomal doxorubicin, 20-30 mg/m², ivgtt day 2 or Epirubicin, 50-60 mg/m², ivgtt day 2); Vincristine, 1.4 mg/m², iv day 2 or vindesine, 3mg/m², iv day 2; Prednisone, 100 mg qd, po day 2-6.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed DLBCL * Without treatment * ≥ 65 years old * Measurable lesions on CT or PET-CT before treatment * Life expectancy of at least 3 months * Voluntary participation with the consent of the patient * Heart, kidney, liver and other organ function evaluation were basically normal before treatment Exclusion Criteria: * Patients who previously received chemotherapy * Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases * Laboratory indicators before enrollment (unless caused by lymphoma): * Neutrophils \< 1.5 × 10\^9/L * Platelets \< 80 × 10\^9/L * Alanine aminotransferase or aspartate aminotransferase \> 2 × ULN * Alkaline phosphatase or bilirubin \> 1.5 × ULN * Creatinine \> 1.5 × ULN * Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation * HIV infection * If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled * Other uncontrolled medical conditions that may interfere with the study
References
Publications (0)
Data not yet available
No reference posted for this study.