About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Polatuzumab Vedotin
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Prednisone