Clinical trial · Interventional
ZR-CHOP in DLBCL With Specific Gene Abnormality
Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
NCT05290337CI-TRIAL-00057264unknownPhase 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 phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZR-CHOP
- interventionNames
- Drug: zanubrutinib
Primary outcomes (1)
- measure
- 3-year progression free survival
- timeFrame
- assessed up to 36 months
- description
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Secondary outcomes (3)
- measure
- Objective response rate
- timeFrame
- assessed up to 36 months
- description
- complete remission and partial remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-75 years old; 2. histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation; 3. Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center- 4. normal hematological, hepatic and renal function. 5. Life expectancy of more than 3 months; 6. Patients had at least one measurable target lesion; 7. LVEF ≥ 50% 8. signed informed consent forms Exclusion Criteria: 1. hypersensitivity to immunoglobulin; 2. primary central nerves lymphoma 3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; 4. With contraindication of steroid including uncontrolled diabetes; 5. Serious uncontrolled diseases and intercurrent infection; 6. Pregnant or lactating women; 7. hepatitis B infection with HBV-DNA ≥ 104
References
Publications (1)
- DERIVEDZhang Q, Jiang S, Wei R, Zhang W, Bao L, Liu Y, Jin J, Lv F, Liu C, Liu X, Sun H, Wang J, Tao R, Zhou X, Cao J. Zanubrutinib combined with R-CHOP in previously untreated diffuse large B-cell lymphoma with specific gene alteration: a phase II study. Blood Cancer J. 2026 Jul 1. doi: 10.1038/s41408-026-01553-4. Online ahead of print. PMID 42386710