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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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

Treatment groups

134 Participants
are divided into 2 treatment groups