Polatuzumab Vedotin: Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab: Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide: Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm
Doxorubicin: Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone: Prednisone PO will be administered as per the schedule specified in the respective arm.
Study summary
This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete response rate (CR) — up to the end of 6 cycles of treatment (each cycle is 28 days)] To assess the complete response rate (CR) at the end of treatment with Treatment
Trial sites (1)
Facility
City
Region
Status
China Institute of Hematology and Blood Diseases Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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