A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have just been diagnosed with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL). Researchers want to find out if giving 4 cycles of a chemotherapy combination called CHP (given every 3 weeks) works just as well and is as safe as giving the usual 6 cycles, when both are combined with two other medicines, polatuzumab vedotin and rituximab. The goal is to see if a shorter treatment can provide the same benefits, potentially reducing side effects and treatment time.

People who might be eligible for this study are adults between 18 and 80 years old who have never been treated for DLBCL, have a low-risk score based on their disease (called IPI 0-1), and meet certain health requirements like good heart function and measurable disease on scans. If you join, you will receive either 4 or 6 cycles of chemotherapy with the added medicines, and doctors will closely monitor your response and side effects. This study is not yet recruiting, but it offers a chance to take part in testing a potentially easier treatment plan with careful medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL)
• • Age ≥18yo and ≤80yo at the time of signing consent
• • International Prognostic Index (IPI) score 0-1
• • ECOG 0-2
• • Have measurable disease on a pre-chemotherapy PET/CT, defined as at least one bi-dimensionally measurable nodal lesion of \>1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of \>1.0cm in longest dimension
• • Life expectancy greater than or equal to (\>/=)12 months
• • Left ventricular ejection fraction (LVEF) \>/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
• • Adequate hematologic function
• • Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.
• • Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.
• Exclusion Criteria:
• • Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma.
• • Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.
• • Pregnant or lactating women.
• • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction \[PCR\]) infection.
• • Patients with concurrent other tumors or a history of tumors, or who have received anti-tumor treatment (including major surgery) within the last 4 weeks.
• • Allergic reactions to polatuzumab vedotin.
• • Other conditions where the investigator deems the patient ineligible for this study.