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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07034508
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
  • Rituximab — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Cyclophosphamide — DRUG
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm
  • Doxorubicin — DRUG
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
  • Prednisone — DRUG
    Prednisone PO will be administered as per the schedule specified in the respective arm.

Study Details

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

Key Dates

Start date
Jun 20, 2025
Status verified
Jun 2025
Primary completion
Dec 20, 2027
Completion
Dec 20, 2029

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4×Pola-RCHP followed by 2×Pola-R
    Participants will receive: Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles. Rituximab: 375 milligrams per square meter (mg/m\^2) IV on Day 1 of every cycle for 6 cycles. Cyclophosphamide: 750 mg/m\^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m\^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles. This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
  • Active Comparator: 6×Pola-RCHP
    Participants will receive: Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles. Rituximab: 375 milligrams per square meter (mg/m\^2) IV on Day 1 of every cycle for 6 cycles. Cyclophosphamide: 750 mg/m\^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m\^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles. This regimen is repeated for 6 cycles

Primary Outcome Measure

Complete response rate (CR) [ Time Frame: up to the end of 6 cycles of treatment (each cycle is 28 days)] ]

Central Contacts

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