At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Zilovertamab vedotin (biological), Rituximab (biological), Gemcitabine (drug), Oxaliplatin (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Zilovertamab vedotin — biological: Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg · Rituximab — biological: IV Infusion 375 mg/m\^2 · Gemcitabine — drug: IV Infusion 1000 mg/m\^2 · Oxaliplatin — drug: IV Infusion 100 mg/m\^2 · Bendamustine — drug: IV Infusion 90 mg/m\^2 · Granulocyte Colony-Stimulating Factor (G-CSF) — drug: Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 290
- Started
- 2022-01-14
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for dlbcl
- • Phase2/Phase3 - 290 participants
- • The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with dlbcl
Where?
- • Aberdeen - Aberdeen Royal Infirmary ( Site 2104)
- • Truro - The Royal Cornwall Hospital ( Site 2103)
- • London-Camden - University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Has a confirmed by a biopsy diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
- ✓Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
- ✓Has an activity scale (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment...
- ✓Has healthy organ.
- ✓Is able to provide new or archival tumor tissue sample not previously irradiated.
Who cannot take part
- ✗Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
- ✗Has received solid organ transplant at any time.
- ✗Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
- ✗Has clinically significant (ie, active) cardiovascular disease or serious heart arrhythmia requiring medication.
- ✗Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
See the full criteria
Where Is This Study? (3 UK sites)
Aberdeen Royal Infirmary ( Site 2104)
Aberdeen AB25 2ZN, United Kingdom
The Royal Cornwall Hospital ( Site 2103)
Truro TR1 3LJ, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
London-Camden NW1 2PG, United Kingdom
How to Get in Touch
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