Trial · NCT04535102
POLA+BR for Relapsed or Refractory DLBCL
NCT04535102, Phase 2, Withdrawn, University of Colorado, Denver
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. POLA+BR for Relapsed or Refractory DLBCL. Trials, record NCT04535102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04535102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- POLA+BR for Relapsed or Refractory DLBCL
- NCT number
- NCT04535102
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Polatuzumab Vedotin
- First posted
- 2020-09-01
- Last updated
- 2022-05-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response at primary response | 3 weeks after last dose of study medication | The assessment is based on PET/CT, as determined by the investigator |
| Primary | objective response at primary response | 3 weeks after last dose of study medication | assessment based on PET/CT as determined by the investigator |
| Primary | duration of response (DOR) of combination therapy | 2 years of follow up | DOR, defined as the time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause based on PET/CT or CT only as determined by the investigator assessment.Response assessment will be determined according to Modified Lugano Response Criteria for Malignant Lymphoma (Lugano Classification) |
| Primary | number of patients who underwent an ASCT | 2 years of follow up | Determined during follow up |
| Primary | Cell of Origin analysis | 2 years of follow up | Cell of origin analysis will be based on immunohistochemistry analysis |
| Primary | Differences in response rates based on timing of relapse | 2 years of follow up | \<12 months of front-line R-chemotherapy versus \>12 months after front-line R-chemotherapy and bulky disease prior to ASCT (bulk defined as mass \> 7.5 cms) |
| Primary | c-Myc status | 2 years of follow up | by FISH |
| Primary | 2-yr progression free survival (PFS) | 2 years of follow up | PFS, defined as the time from date of first treatment to the first occurrence of progression or relapse, or death from any cause, based on PET/CT or CT only as determined by the investigator assessment |
| Primary | overall survival (OS) | 2 years of follow up | defined as the time from the date of randomization or first treatment to the date of death from any cause |
| Primary | stem cell collection failure rate | 2 years of follow up | Stem cells will be collected post primary response assessment. If patients achieve a PR after 3 cycles of Pola+BR and investigator decides to give additional cycles of Pola+BR (up to a max of 6 cycles) then stem cell collection may occur between cycles to minimize the chances of collection failure. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA046934 | University of Colorado Cancer Center Support Grant | DEGREGORI, JAMES V | UNIVERSITY OF COLORADO DENVER | NATIONAL CANCER INSTITUTE | 1988 to 2025 |
Source NIH RePORTER
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/NCT04535102
GET https://conductscience.org/api/trials/v1/NCT04535102/registered