Trial · NCT04680052
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
NCT04680052, Phase 3, Active not recruiting, Incyte Corporation; results first posted 2025-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Trials, record NCT04680052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04680052
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
- NCT number
- NCT04680052
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 654 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Follicular Lymphoma, Marginal Zone Lymphoma
- Interventions
- tafasitamab, rituximab, lenalidomide, placebo
- First posted
- 2020-12-22
- Last updated
- 2026-09-04
- Other registries' IDs
- eudract:2020-004407-13
- Results first posted
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| Primary | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| Secondary | Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| Secondary | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| Secondary | FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. |
| Secondary | FL Population: Overall Survival | up to approximately 34 months | Overall survival was defined as the time from randomization until death from any cause. |
| Secondary | FL Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| Secondary | FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5. |
| Secondary | FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | up to approximately 34 months | The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. |
| Secondary | Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | up to approximately 34 months | The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| PRIMARY | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | FL FDG-avid Set: all randomized participants with FL and with a PET scan at Baseline with a resulting Deauville score of 4 or 5. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Overall Survival | up to approximately 34 months | FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | FL Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | up to approximately 34 months | FL MRD Blood-Evaluable Set: all participants in the Full Analysis Set with FL who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | up to approximately 34 months | Overall MRD Blood-Evaluable Set. As pre-specified in the Statistical Analysis Plan, the MZL population was a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis. | percentage of participants | NUMBER |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group508
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | FL: Tafasitamab + Rituximab + Lenalidomide | 22.37 | 95% Confidence Interval 19.22 to NA | months | |
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | FL: Placebo + Rituximab + Lenalidomide | 13.93 | 95% Confidence Interval 11.53 to 16.39 | months | |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Tafasitamab + Rituximab + Lenalidomide | 6 months | 92.4 | 95% Confidence Interval 88.3 to 95.1 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Placebo + Rituximab + Lenalidomide | 6 months | 78.2 | 95% Confidence Interval 72.7 to 82.7 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Tafasitamab + Rituximab + Lenalidomide | 12 months | 79.0 | 95% Confidence Interval 72.8 to 84.0 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Placebo + Rituximab + Lenalidomide | 12 months | 54.0 | 95% Confidence Interval 47.1 to 60.5 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Tafasitamab + Rituximab + Lenalidomide | 18 months | 61.9 | 95% Confidence Interval 53.4 to 69.3 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Placebo + Rituximab + Lenalidomide | 18 months | 38.5 | 95% Confidence Interval 30.8 to 46.1 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Tafasitamab + Rituximab + Lenalidomide | 2 years | 41.7 | 95% Confidence Interval 28.4 to 54.6 | percent probability |
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | FL: Placebo + Rituximab + Lenalidomide | 2 years | 31.8 | 95% Confidence Interval 23.6 to 40.2 | percent probability |
1 to 10 of 508Source ClinicalTrials.gov
See all 508 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FL: Tafasitamab + Rituximab + Lenalidomide | 273 | |
| Overall Study | STARTED | FL: Placebo + Rituximab + Lenalidomide | 275 | |
| Overall Study | STARTED | MZL: Tafasitamab + Rituximab + Lenalidomide | 53 | |
| Overall Study | STARTED | MZL: Placebo + Rituximab + Lenalidomide | 53 | |
| Overall Study | COMPLETED | FL: Tafasitamab + Rituximab + Lenalidomide | 0 | |
| Overall Study | COMPLETED | FL: Placebo + Rituximab + Lenalidomide | 0 | |
| Overall Study | COMPLETED | MZL: Tafasitamab + Rituximab + Lenalidomide | 0 | |
| Overall Study | COMPLETED | MZL: Placebo + Rituximab + Lenalidomide | 0 | |
| Overall Study | NOT COMPLETED | FL: Tafasitamab + Rituximab + Lenalidomide | 273 | |
| Overall Study | NOT COMPLETED | FL: Placebo + Rituximab + Lenalidomide | 275 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events630
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Tafasitamab + Rituximab + Lenalidomide | 25 | 327 | 33 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Rituximab + Lenalidomide | 28 | 325 | 30 |
| other | Abdominal pain | Gastrointestinal disorders | Total | 53 | 652 | 63 |
| other | Alanine aminotransferase increased | Investigations | Tafasitamab + Rituximab + Lenalidomide | 19 | 327 | 28 |
| other | Alanine aminotransferase increased | Investigations | Placebo + Rituximab + Lenalidomide | 23 | 325 | 36 |
| other | Alanine aminotransferase increased | Investigations | Total | 42 | 652 | 64 |
| other | Anaemia | Blood and lymphatic system disorders | Tafasitamab + Rituximab + Lenalidomide | 53 | 327 | 97 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Rituximab + Lenalidomide | 46 | 325 | 73 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 99 | 652 | 170 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Tafasitamab + Rituximab + Lenalidomide | 24 | 327 | 25 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tafasitamab + Rituximab + Lenalidomide | 22 | 327 |
| Total, all-cause mortality | Placebo + Rituximab + Lenalidomide | 24 | 325 |
| Total, all-cause mortality | Total | 46 | 652 |
| Total, other adverse events | Tafasitamab + Rituximab + Lenalidomide | 318 | 327 |
| Total, other adverse events | Placebo + Rituximab + Lenalidomide | 315 | 325 |
| Total, other adverse events | Total | 633 | 652 |
| Total, serious adverse events | Tafasitamab + Rituximab + Lenalidomide | 125 | 327 |
| Total, serious adverse events | Placebo + Rituximab + Lenalidomide | 110 | 325 |
| Total, serious adverse events | Total | 235 | 652 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41360064 | 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.
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GET https://conductscience.org/api/trials/v1/NCT04680052
GET https://conductscience.org/api/trials/v1/NCT04680052/registered?page=2