Trial · NCT04824092
Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
NCT04824092, Phase 3, Active not recruiting, Incyte Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients. Trials, record NCT04824092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04824092
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
- NCT number
- NCT04824092
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 899 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Tafasitamab, Lenalidomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tafasitamab placebo, Lenalidomide placebo
- First posted
- 2021-04-01
- Last updated
- 2026-04-01
- Other registries' IDs
- eudract:2020-002990-84
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS-INV | Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months) | Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma |
| Secondary | EFS-INV | From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months) | Event-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma |
| Secondary | OS | From randomization until the date of death from any cause (up to 62 months) | Overall Survival |
| Secondary | Metabolic PET-negative CR-rate at EOT by BIRC | End of treatment, 4-8 weeks after last dose | Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by BIRC |
| Secondary | Metabolic PET-negative CR-rate at EOT by INV | End of treatment, 4-8 weeks after last dose | Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by the investigator |
| Secondary | ORR as per INV at EOT | 6 ± 2 weeks after End of Treatment | Overall response rate defined as the proportion of patients with CR or PR as per Lugano 2014 criteria based on assessment at the end of the treatment by the INV |
| Secondary | Time to next anti-lymphoma treatment (TTNT) | From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months) | TTNT is defined as the time from randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first. |
| Secondary | Duration of Complete Response (CR) as assessed by the investigator | From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months) | Duration of CR is defined as the time from the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier for the subgroup of patients with a Best Overall Response (BOR) of CR. |
| Secondary | EFS at 3 years | 36 months after randomization | Event-Free Survival as assessed by the investigator |
| Secondary | PFS at 3 years | 36 months after randomization | Progression-Free Survival as assessed by the investigator |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers4
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/NCT04824092
GET https://conductscience.org/api/trials/v1/NCT04824092/registered