Trial · NCT06071871
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | Part 2: Response rate for patients who received Pola-Glofit bridging versus those who have not | From the date of registration until Cycle 5 (approximately 12 weeks. Each cycle is 21 days). | Per Lugano 2014 criteria. Response rates following 2 and 5 cycles of Part 2 treatment. |
| Secondary | Part 2: Safety and toxicity of Pola-Glofit post CAR-T therapy | Throughout Part 2 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 2. |
| Secondary | Part 2: Overall Survival (OS) | From the date of registration for Part 2 until the date of death, assessed up to 4 years. | Median (if reached), rates at 6 months and 1 year (with 95% CIs) and plots will be presented. |
| Secondary | Part 2: Duration of Response (DoR) | From the date of first response until disease progression, assessed up to 4 years. | Response defined as PMR (partial metabolic response) or better. |
| Secondary | Part 2: Duration of Complete Response (DoCR) | From the date of first complete metabolic response (CMR) until disease progression, assessed up to 4 years. | |
| Secondary | Part 2: Non-Relapse Mortality (NRM) | NRM will be measured 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 will be presented at 6 months and 1 year. | NRM rates will be presented at 6 months and 1 year. |
| Secondary | Part 2: Progression Free Survival (PFS) (at 12 months) | PSF will be measured from the date of registration at Part 2 until the date of disease progression. This will be assessed from the date of registration until up to 4 years. The median rate at 12 months will be presented. | Median (if reached), rate at 12 months (with 95% CI) and plot will be presented |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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