A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

Conditions

• 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.
• Vincristine — DRUG
  Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine Placebo — DRUG
  Placebo matching to vincristine 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.
• Polatuzumab vedotin Placebo — DRUG
  Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Study Details

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Key Dates

Start date

Nov 16, 2017

Status verified

May 2026

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

1,000 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
  Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m\^2) IV, cyclophosphamide 750 mg/m\^2 IV, and doxorubicin 50 mg/m\^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.
• Placebo Comparator: R-CHOP plus Polatuzumab Vedotin Placebo
  Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m\^2 IV, cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV (maximum 2 milligrams per dose \[mg/dose\]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [ Time Frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months) ]

Locations (49)

Find similar trials in Birmingham, AL

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