Trial · NCT05409066
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
NCT05409066, Phase 3, Active not recruiting, Genmab
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma. Trials, record NCT05409066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05409066
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
- NCT number
- NCT05409066
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 549 participants, actual
- Lead sponsor
- Genmab
- Conditions
- Follicular Lymphoma (FL)
- Interventions
- Epcoritamab, Rituximab, Lenalidomide
- First posted
- 2022-06-08
- Last updated
- 2026-07-08
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Best Overall Response (BOR) | Up to approximately 2 years and 3 months | BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC. |
| Primary | Progression-Free Survival (PFS) | Up to approximately 2 years and 3 months | PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first). |
| Secondary | Percentage of Participants Achieving CR | Up to approximately 5 years | Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Overall Survival (OS) | Up to approximately 8 years from randomization | Overall survival is defined as the duration from the date of randomization to the date of the participant's death. |
| Secondary | Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity | Up to approximately 5 years | MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) | Up to approximately 8 years | The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life. |
| Secondary | PFS as Assessed by Investigator | Up to approximately 5 years | PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first). |
| Secondary | Percentage of Participants Achieving BOR as Assessed by Investigator | Up to approximately 5 years | BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator. |
| Secondary | Percentage of Participants Achieving CR as Assessed by Investigator | Up to approximately 5 years | Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Duration of Response (DOR) | Up to approximately 8 years | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
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 |
|---|---|
| 41371238 | 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/NCT05409066
GET https://conductscience.org/api/trials/v1/NCT05409066/registered?page=2