Trial · NCT05800366
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
NCT05800366, Phase 2, Recruiting, Jennifer Crombie, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma. Trials, record NCT05800366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05800366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
- NCT number
- NCT05800366
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, estimated
- Lead sponsor
- Jennifer Crombie, MD
- Conditions
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
- Interventions
- Glofitamab, Polatuzumab, Rituximab, Doxorubicin Hydrochloride, Cyclophosphamide, Prednisone
- First posted
- 2023-04-05
- Last updated
- 2026-03-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | Baseline through 28 days post Cycle 8 of Glofitamab (each cycle is 21 days) | The complete response (CR) Rate is the proportion of participants achieving CR based on Lugano criteria defined per protocol section 11.1.1 for target lesions. |
| Secondary | Dose-Limiting Toxicity (DLT) | 42 days | A DLT will be defined as any of the adverse events (AE) in protocol section 5.4.1 defined toxicities that are determined to be at least possibly related to glofitamab-pola-R-CHP. |
| Secondary | Grade 3-5 Treatment-related Toxicity Rate | Up to 9 months | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation. |
| Secondary | Overall Response Rate (ORR) | 8 months | The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on criteria defined per protocol section 11.1.1. |
| Secondary | Median Duration of Response (DOR) | Up to 24 months | Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per protocol defined section 11.1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment. |
| Secondary | Median Progression-Free Survival (PFS) | Up to 24 months | Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) per Lugano criteria or death, or is censored at time of last disease assessment. |
| Secondary | 1-Year Progression Free Survival rate | 1 year | 1-year PFS rate is the proportion of participants remaining alive and progression free at 1 year. Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. PD is defined per Lugano 2014 criteria. |
| Secondary | Median Overall Survival (OS) | up to 5 years | Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
| Secondary | Change in ctDNA level from Baseline to 2 cycles by Objective Response Status or PFS or OS | Baseline and end of cycle 2 (each cycle is 21 days) | ctDNA will be measured using the Avenio assay. |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|
| 42837325 | 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/NCT05800366
GET https://conductscience.org/api/trials/v1/NCT05800366/registered