Phase 3
N=15
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT04182204 ↗Enrolled (actual)
15
Serious AEs
34.3%
Results posted
Dec 2025
Primary outcome: Primary: Stage 1: Number of Participants With Adverse Events (AEs) — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Polatuzumab Vedotin (Drug); Rituximab (Drug); Gemcitabine (Drug); Oxaliplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Number of Participants With Adverse Events (AEs) |
14 | — |
| PRIMARY Stage 1: Number of Participants With Peripheral Neuropathy (PN) |
8 | — |
| PRIMARY Stage 2: Overall Survival (OS) |
12.5; 19.5 | 0.0017 sig |
| SECONDARY Stage 1 and Stage 2: Progression-free Survival (PFS) |
3.9; 2.7; 7.4 | <0.0001 sig |
| SECONDARY Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment |
19.0; 40.3 | <0.0001 sig |
| SECONDARY Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment |
24.6; 52.7 | <0.0001 sig |
| SECONDARY Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator |
46.7; 34.9; 65.1 | — |
| SECONDARY Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment |
20.0; 18.3; 35.7 | — |
| SECONDARY Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment |
26.7; 24.6; 45.0 | — |
| SECONDARY Stage 2: Duration of Response (DOR) |
8.5; 11.8 | — |
| SECONDARY Stage 1 and Stage 2: Event-free Survival (EFSeff) |
3.9; 2.7; 6.8 | — |
| SECONDARY Stage 2: Time to Deterioration in Physical Functioning as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30) |
2.8; 8.1 | — |
| SECONDARY Stage 2: Time to Deterioration in Fatigue Scale as Measured by the EORTC QLQ-C30 |
1.4; 1.8 | — |
| SECONDARY Stage 2: Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Subscale (FACT-Lym LymS) |
2.5; 4.6 | — |
| SECONDARY Stage 2: Change From Baseline in Physical Functioning as Measured by EORTC QLQ-C30 |
65.65; 71.08; -0.88; 0.94; -1.10; 2.16 | — |
| SECONDARY Stage 2: Change From Baseline in Fatigue Scale as Measured by EORTC QLQ-C30 |
34.99; 35.13; 2.81; 2.57; 2.04; 0.05 | — |
| SECONDARY Stage 2: Change From Baseline in FACT-Lym LYMS Scores |
41.73; 42.49; 0.49; 2.12; 1.71; 2.66 | — |
| SECONDARY Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item (FACT/GOG-NTX-12) Scores |
40.67; 40.37; -1.56; -0.54; -1.35; -0.20 | — |
| SECONDARY Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Physical Functioning Scale |
31.0; 41.1 | — |
| SECONDARY Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Fatigue Scale |
46.0; 55.8 | — |
| SECONDARY Stage 2: Percentage of Participants With Clinically Meaningful Improvement in FACT-Lym LYMS |
48.4; 66.7 | — |
| SECONDARY Stage 2: Number of Participants With AEs |
117; 125 | — |
| SECONDARY Stage 2: Number of Participants With PN |
36; 73 | — |
| SECONDARY Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin |
3; 22 | — |
| SECONDARY Stage 1 and Stage 2: Dose Intensity of Polatuzumab Vedotin |
93.60; 92.81 | — |
| SECONDARY Stage 1: OS |
12.6 | — |
| SECONDARY Stage 1 and Stage 2: Percentage of Participants With Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin |
0; 2.6 | — |
Summary
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
- Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that did not respond to or that progressed during therapy or progressed within 6 months ( 1.5 cm in its longest dimension as measured by CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Adequate hematological function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm,
Exclusion Criteria
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to rituximab, gemcitabine or oxaliplatin
- Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0
- Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks
- Planned autologous or allogenic stem cell transplantation or CAR T-cell therapy at time of recruitment
- Primary or secondary central nervous system (CNS) lymphoma
- Richter's transformation or prior CLL
- Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- Vaccination with a live vaccine within 4 weeks prior to treatment
- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
- Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
Data sourced from ClinicalTrials.gov (NCT04182204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.