Using Zanubrutinib with R-CHOP for a specific type of lymphoma
Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
PHASE2 · Fudan University · NCT05290337
This study is testing if combining Zanubrutinib with R-CHOP can help people with newly diagnosed diffuse large B-cell lymphoma that has certain gene changes.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Drugs / interventions | Zanubrutinib |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05290337 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the efficacy and safety of Zanubrutinib in combination with R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma that has specific gene abnormalities, such as MYC translocation and various mutations. The trial is conducted at a single center, Fudan University Shanghai Cancer Center, and involves administering six cycles of the combined therapy. The goal is to determine how well this treatment works for patients with these genetic markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed diffuse large B-cell lymphoma and specific gene abnormalities.
Not a fit: Patients with primary central nervous system lymphoma or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective therapy option for patients with specific genetic abnormalities in diffuse large B-cell lymphoma.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diffuse Large B Cell Lymphoma, Zanubrutinib, gene mutation, MYC translocation