Trial · NCT04915248
Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
NCT04915248, Phase 2, Recruiting, Fondazione Italiana Linfomi - ETS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients. Trials, record NCT04915248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04915248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
- NCT number
- NCT04915248
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Conditions
- Plasmablastic Lymphoma
- Interventions
- Daratumumab, Bortezomib, Dexamethasone
- First posted
- 2021-06-07
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | 30 months | Response assessment will be done at each restaging. The best overall response will be defined as the best response between the date of beginning of therapy and the last response evaluation. Patients without response assessment (due to whatever reason) will be considered as non-responders. |
| Secondary | Progression-free survival (PFS) | 30 months | From the date of starting therapy and the date of disease progression, relapse or death from any cause. Responding patients according to the Lugano classification response Criteria and patients who are lost to follow-up will be censored at their last assessment date. |
| Secondary | Overall survival (OS) | 30 months | From the date of starting therapy and the date of death from any cause. Patients alive and those who are lost to follow-up at the time of the final analysis will be censored at the date of the last contact. |
| Secondary | Duration of response (DOR) | 30 months | For all patients who achieved a response (CR or PR) according to Response Criteria for NHL with PET (Lugano 2014) and it is measured from the date when criteria for response are met (CR or PR) until the date of progression (including death due to progression) or relapse. Patients without relapse or progression or with death from other cause than progression will be censored at their last assessment date. |
| Secondary | Number of participants with treatment-related adverse events as assessed by current version of CTCAE. | 30 months | The safety of daratumumab as single agent and in combination with bortezomib/dexamethasone will be assessed in all patients who have received at least one dose of study medication. Rates of adverse events and of serious adverse events will be will be presented with two sided 95% confidence intervals. |
| Secondary | Rate of Complete Remission (CRR) | 30 months | Comparison of ORR and CRR before and after maintenance, and by evaluation of rate of conversion of SD to PR and of SD/PR to CR with daratumumab maintenance. |
| Secondary | Relationship between CD38 expression on lymphoma cells, assessed by immunohistochemistry, and the response rate. | 30 months | The extent of CD38 expression evaluated by immunochemistry on the diagnostic biopsy-tissue will be correlated with response measured according to the Lugano 2014 criteria at various timepoints: after induction cycle 1, after induction cycles 3, 6 and 9 (end of induction, EOI); after maintenance cycles 12 and 15 (end of treatment, EOT). correlated with response measured according to the Lugano 2014 criteria at various endpoints. |
| Secondary | Impact of daratumumab and bortezomib treatment on biological cell profiles. | 30 months | The impact of daratumumab and bortezomib treatment in immune activation (CD38, CD25, HLA-DR), T cell differentiation (naïve, central memory, effector memory and terminal effector memory T cell subset) and on circulating myeloid-derived suppressor cells (MDSC) as well as Treg will be evaluated by multiparametric flow cytometry (84 multiple staining). Peripheral blood samples will be collected in different timepoints: before treatment start; after cycle 1; after cycle 3 and at EOT. |
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.
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/NCT04915248
GET https://conductscience.org/api/trials/v1/NCT04915248/registered