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A single arm and prospective clinical trial of zanubrutinib plus R-CHOP in untreated double expression diffuse large B-Cell Lymphoma with international prognostic index equal or greater than 2 scores

A single arm and prospective clinical trial of zanubrutinib plus R-CHOP in untreated double expression diffuse large B-Cell Lymphoma with international prognostic index equal or greater than 2 scores

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039456
Enrollment
Unknown
Registered
2020-10-28
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

double expressing diffuse large B-cell lymphoma

Interventions

Group1:zanubrutinib plus R-CHOP

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 6 months; 6. Liver function: alanine aminotransferase (AST) and aspartate aminotransferase (ALT) = 3.0 x 10^9/L, neutrophil absolute value (ANC) >= 1.5 x 10^9/L, platelet (PLT) >= 75 x 10^9/L, hemoglobin (Hb) >= 90 g/L; 9. Cardiac function: Echocardiography of left ventricular ejection fraction (LVEF) >= 50%; 10. Sign informed Consent.

Exclusion criteria

Exclusion criteria: 1. Patients with primary central nervous system lymphoma; 2. Severe diseases that may limit the patient's participation in this trial (e.g., advanced infections, uncontrolled diabetes, uncontrolled hypertension, severe cardiac or angina, hepatic or renal insufficiency, etc.); 3. A history of other tumors, except cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 4. Hiv-infected persons (HIV-positive); 5. Acute or chronic active hepatitis B and HBV DNA > 1*104; 6. A history of severe neurological or psychiatric problems, including dementia or epilepsy; 7. Patients who have already received chemotherapy for DLBCL, except for short course and low dose hormone; 8. The researchers considered it inappropriate to enroll.

Design outcomes

Primary

MeasureTime frame
one year progression free survival;

Secondary

MeasureTime frame
Objective response rate;CRR;Side effect;

Countries

China

Contacts

Public ContactZou Liqun

West China Hospital, Sichuan University

zliqun@hotmail.com+86 18980601027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026