Trial · NCT06071871
A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
NCT06071871, Phase 2, Recruiting, University College, London
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma. Trials, record NCT06071871. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06071871
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
- NCT number
- NCT06071871
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 99 participants, estimated
- Lead sponsor
- University College, London
- Conditions
- Large B-cell Lymphoma
- Interventions
- Glofitamab, Polatuzumab vedotin, Obinutuzumab
- First posted
- 2023-10-10
- Last updated
- 2024-12-24
- Other registries' IDs
- eudract:2022-003727-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Overall Response Rate (ORR) to Pola-Glofit as bridging prior to CAR-T cell infusion | At Cycle 2 Day 14-19 (or earlier) (each cycle is 21 days) | To determine the efficacy of Pola-Glofit as bridging treatment to CAR-T cell therapy in patients with r/r LBCL. ORR i.e. the proportion of patients achieving response (Complete Metabolic Response or Partial Metabolic Response) after Pola-Glofit bridging but prior to CAR-T cell infusion, assessed by central review as per 2014 Lugano Classification. This will be presented as a rate with a 70% confidence interval. |
| Primary | Part 2: Progression Free Survival (PFS) at 6 months | From the date of registration at Part 2 until the date of first disease progression or death, whichever comes first, assessed up to 4 years | To determine the efficacy of Pola-Glofit in patients with LBCL who have failed to achieve CMR, or progressed after CAR-T cell therapy. PFS at 6 months will be analysed using Kaplan-Meier survival analysis, with the rate at 6 months (with 70% CI) presented. The median (if reached) and plot will also be given. |
| Secondary | Part 1: Complete Metabolic Response (CMR) rate to Pola-Glofit as bridging prior to CAR-T cell infusion | At Cycle 2 Day 14-19 of bridging treatment (each cycle is 21 days) | Per Lugano 2014 criteria |
| Secondary | Part 1: Overall Survival (OS) and Progression Free Survival (PFS) | From the date of registration at Part 1 until the date of disease progression or death (PFS), or death (OS). This will be assessed from the date of registration until up to 4 years. | Medians (if reached), rates at 6 months and 1 year and plots will be presented |
| Secondary | Part 1: Safety and toxicity of Pola-Glofit as bridging therapy | From registration and during Part 1 bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of obinutuzumab, plus a further 35 days after last dose of polatuzumab vedotin or last dose of glofitamab) | Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events. Assessed in all patients given at least one dose of study treatment in part 1. |
| Secondary | Part 1: CAR-T associated toxicity post Pola-Glofit bridging following CAR-T therapy | Between Day 0 and Day 28 following CAR-T therapy | Assessed in all patients given at least one dose of study treatment in part 1 and infused. Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events. |
| Secondary | Part 1: Response rate post CAR-T for all infused patients | From CAR-T infusion until 6 months post CAR-T therapy | Per Lugano 2014 criteria. Response rates at 1, 3 and 6 months post CAR-T therapy. |
| Secondary | Part 1: Duration of Response (DoR) and Duration of Complete Response (DoCR) for Pola-Glofit and CAR-T | From the date of first response until disease progression. This will be assessed from the date of registration until up to 4 years. | Response defined as PR (partial response) or better. |
| Secondary | Part 1: Non-Relapse Mortality (NRM) | From the date of registration until the date of NRM. This will be assessed from the date of registration until up to 4 years. | NRM rates at 6 months and 1 year |
| Secondary | Part 2: Complete Metabolic Response (CMR) rate to Pola-Glofit/Glofitamab at any point | From the date of registration until up to 4 years | Per Lugano 2014 criteria |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41894687 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06071871
GET https://conductscience.org/api/trials/v1/NCT06071871/registered