Trial · NCT05966233
R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma
NCT05966233, Phase 2, Withdrawn, Fondazione Italiana Linfomi - ETS
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma. Trials, record NCT05966233. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05966233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma
- NCT number
- NCT05966233
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Conditions
- Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent
- Interventions
- R-DHAP, Pola-R-DHAP
- First posted
- 2023-07-28
- Last updated
- 2024-05-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) | From treatment start up to 30 months (6 months treatment period and 24 months of follow-up) | Time between the randomization to first documentation of recurrence, progression or death from any cause |
| Secondary | Event-Free Survival (EFS) | From treatment start up to 30 months (6 months treatment period and 24 months of follow-up) | Time between the randomization to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause. |
| Secondary | Complete response rate (CRR) | From treatment start up to end of treatment evaluation (about 6 months) | CRR will be defined according to Response Criteria for NHL with PET (Lugano 2014). CRR will include only patients who achieved a CR and will be evaluated on assessed patients and on all treated patients, considering patients without a response assessment (due to any reason) as non-responders. |
| Secondary | Overall response rate (ORR) | From treatment start up to end of treatment evaluation (about 6 months) | ORR will be defined as the proportion of patients who have a partial or complete response to therapy (CR+PR). |
| Secondary | Overall Survival (OS) | From treatment start up to 30 months (6 months treatment period and 24 months of follow-up) | Time between randomization to death from any cause. |
| Secondary | Incidence and severity of AEs | From start to end of induction treatment evaluation (about 3 months) | Incidence and severity of AEs in R-DHAP vs POLA-R-DHAP according to latest CTCAE criteria during induction immunochemotherapy |
| Secondary | Adequate stem cells mobilization | From beginning of 2nd cycle to end of induction treatment evaluation (about 2 months) | Adequate stem cells mobilization will be defined by the target cell harvesting of 3 x 10\^6 CD34+ cells/kg |
| Secondary | Autologous consolidation feasibility | At time of end of treatment assessment (up to 6 months from treatment begin) | Proportion of patients receiving autologous consolidation after POLA-R-DHAP vs R-DHAP |
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/NCT05966233
GET https://conductscience.org/api/trials/v1/NCT05966233/registered