A phase 3 study that will assess the safety and efficacy of Polatuzumab Vedotin in combination with R-Gemox vs only treatment with R-Gemox in patients having RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-GEMOX ALONE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037317

Enrollment

206

Registered

2021-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C88- Malignant immunoproliferative diseases and certain other B-cell lymphomas

Interventions

Intervention1: Polatuzumab vedotin: 1.8 mg/kg IV on Day 1 of 8 cycles Intervention2: Rituximab: 375 mg/m2 on Day 1 of 8 cycles Intervention3: Gemcitabine: 1000 mg/m2 on Day 2 of 8 cycles Intervention4

Eligibility

Inclusion criteria

Inclusion criteria: Histologically-confirmed diffuse large B-cell lymphoma Relapsed or refractory disease At least one (= 1) line of prior systemic therapy ECOG performance status of 0,1 or 2

Exclusion criteria

Exclusion criteria: Contraindication to rituximab, gemcitabine or oxaliplatin Prior use of polatuzumab vedotin or a gemcitabine + platinum-based agent combination History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), will be assess from randomization to DeathTimepoint: Till the events of 121 deaths in the study	—

Secondary

Measure	Time frame
PFS, CRR and ORRTimepoint: Till the events of 121 deaths in the study	—

Countries

Brazil, Canada, China, Finland, France, Germany, Greece, India, Ireland, Italy, Mexico, Republic of Korea, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States of America

Contacts

Public ContactSharad Junnare

Roche Products (India) Pvt. Ltd.

viraj.suvarna@roche.com9820006317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026