Trial · NCT05848765
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
NCT05848765, Phase 2, Recruiting, University of Birmingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy. Trials, record NCT05848765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05848765
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
- NCT number
- NCT05848765
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 284 participants, estimated
- Lead sponsor
- University of Birmingham
- Conditions
- Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma
- Interventions
- Epcoritamab, Lenalidomide, Rituximab, Obinutuzumab, Bendamustine, Vincristine, Doxorubicin, Cyclophosphamide, Prednisone, Investigation agent 2, Investigation agent 3
- First posted
- 2023-05-08
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete metabolic response (CMR) | 24 weeks | CMR will be assessed by PET-CT using the Deauville 5-point scale and Lugano 2014 criteria. Patients who die from any cause or relapse/progress prior to this time-point will be considered non-responders. Patients who don't have a PET-CT scan within the protocol defined window or withdraw from the trial prior to this time-point will be considered non outcome evaluable. Patients who undergo stem-cell transplant (SCT) within 24 weeks of randomisation, patients who fail to start treatment and patients whose ineligibility is deemed to impact upon response to treatment will be replaced and hence not included in the analysis of this outcome |
| Secondary | Overall metabolic response | 24 weeks | Complete metabolic response (CMR) and partial metabolic response (PMR) will be assessed by PET-CT. Patients who die from any cause or relapse/progress prior to this time-point will be considered non-responders. Patients who undergo stem-cell transplant (SCT) within 24 weeks of randomisation, patients who fail to start treatment and patients whose ineligibility is deemed to impact upon response to treatment will be replaced and hence not included in the analysis of this outcome |
| Secondary | Progression free survival (PFS) | 10 years | The time from randomisation to the date of first disease progression or death. Patients who are alive and relapse/progression at the time of analysis will be censored at their date last seen |
| Secondary | Overall survival (OS) | 10 years | The time from randomisation to the date of death from any cause. Patients who are alive at the time of analysis will be censored at their date last seen |
| Secondary | Duration of response (DoR) | 10 years | The time from complete and partial metabolic response by PET-CT to relapse/progression or death from any cause. Patients who are alive and relapse/progression free at the time of analysis will be censored at their date last seen |
| Secondary | Duration of complete response (DoCR) | 10 years | The time from complete metabolic response by PET-CT to relapse/progression or death from any cause. Patients who are alive and relapse/progression free at the time of analysis will be censored at their date last seen |
| Secondary | Time to next treatment (TTNT) | 10 years | The time from randomisation to the start date of next treatment for lymphoma. Patients who are responding (CMR or PMR) who receive consolidation radiotherapy will not be considered an event and will be censored at their date last seen if no other treatment for lymphoma is reported. Patients who die without having started next lymphoma treatment will be considered a competing risk at their date of death, and patients who are alive and have not started next lymphoma treatment at the time of analysis will be censored at their date last seen |
| Secondary | Adverse events (AEs) | Collected from start of treatment until 60 days after treatment | Collected and reported in accordance with CTCAE version 5 defined as the number of patients who experience one or more grade 3 or 4 adverse events or serious adverse events of any grade |
| Secondary | Quality of Life (QoL) | Collected pre-treatment, day 1 of cycle 3 (28 day cycles), 24 weeks from treatment start and then every 24 weeks in non-progressed patients until the end of the study (10 years) | Measured using the EQ-5D-5L and FACT-Lym |
| Secondary | Quality of Life (QoL) | Collected pre-treatment, day 1 of cycle 3 (28 day cycles), 24 weeks from treatment start and then every 24 weeks in non-progressed patients until the end of the study (10 years) | Measured using the FACT-Lym |
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT05848765
GET https://conductscience.org/api/trials/v1/NCT05848765/registered