Trial · NCT02763319
A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NCT02763319, Phase 2, Phase 3, Completed, Incyte Corporation; results first posted 2025-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL). Trials, record NCT02763319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02763319
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- NCT number
- NCT02763319
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 453 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Rituximab (RTX), Tafasitamab, Bendamustine (BEN)
- First posted
- 2016-05-05
- Last updated
- 2025-07-17
- Other registries' IDs
- eudract:2014-004689-11
- Results first posted
- 2025-07-17
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 41.4 months | Progression-free survival was defined as the time from randomization to tumor progression or death from any cause. |
| Primary | Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 46.5 months | Progression-free survival was defined as the time from randomization to tumor progression or death from any cause. |
| Secondary | Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 77 months | Best ORR was defined as the percentage of patients with complete response (CR) or partial response (PR) based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites. |
| Secondary | Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 77 months | Best ORR was defined as the percentage of patients with CR or PR based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites. |
| Secondary | Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 40.2 months | Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites. |
| Secondary | Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 44.7 months | Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites. |
| Secondary | Kaplan-Meier Estimate of Overall Survival in the Overall Population | up to 50.0 months | Overall survival was defined as the time (in months) from randomization until death from any cause. |
| Secondary | Kaplan-Meier Estimate of Overall Survival in the Natural Killer Cell Count-Low Subgroup | up to 50.6 months | Overall survival was defined as the time (in months) from randomization until death from any cause. |
| Secondary | Disease Control Rate (DCR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 77 months | DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD) based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or progressive disease (PD; any new lesion or an increase by ≥50% of previously involved sites from nadir). |
| Secondary | DCR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 77 months | DCR was defined as the percentage of participants with a CR, PR, or SD based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or PD (any new lesion or an increase by ≥50% of previously involved sites from nadir). |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 41.4 months | Full Analysis Set (FAS): all participants who were randomized to either treatment arm. Participants were analyzed according to the treatment and stratification factors they were assigned to during the randomization procedure. 95% confidence intervals (CIs) (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| PRIMARY | Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 46.5 months | Natural Killer Cell Count-Low Full Analysis Set: participants in the FAS with ≤100 NK cells/µL at Baseline. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 77 months | Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used. | percentage of participants | NUMBER |
| SECONDARY | Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 77 months | Natural Killer Cell Count-Low Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 40.2 months | Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with CR or PR were analyzed. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 44.7 months | Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with CR or PR were analyzed. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival in the Overall Population | up to 50.0 months | Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival in the Natural Killer Cell Count-Low Subgroup | up to 50.6 months | Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | up to 77 months | Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used. | percentage of participants | NUMBER |
| SECONDARY | DCR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | up to 77 months | Natural Killer Cell Count-Low Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used. | percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Tafasitamab + Bendamustine | 7.10 | 95% Confidence Interval 5.800 to 8.500 | months | |
| Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Rituximab + Bendamustine | 8.30 | 95% Confidence Interval 5.600 to 11.500 | months | |
| Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | Tafasitamab + Bendamustine | 5.60 | 95% Confidence Interval 4.400 to 8.600 | months | |
| Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | Rituximab + Bendamustine | 5.60 | 95% Confidence Interval 3.600 to 10.000 | months | |
| Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Tafasitamab + Bendamustine | 65.5 | 95% Confidence Interval 58.90 to 71.67 | percentage of participants | |
| Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Rituximab + Bendamustine | 61.7 | 95% Confidence Interval 55.01 to 68.03 | percentage of participants | |
| Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | Tafasitamab + Bendamustine | 64.8 | 95% Confidence Interval 53.86 to 74.66 | percentage of participants | |
| Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup | Rituximab + Bendamustine | 59.5 | 95% Confidence Interval 47.41 to 70.73 | percentage of participants | |
| Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Tafasitamab + Bendamustine | 7.40 | 95% Confidence Interval 5.800 to 12.100 | months | |
| Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population | Rituximab + Bendamustine | 12.10 | 95% Confidence Interval 10.000 to 23.300 | months |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tafasitamab + Bendamustine | 226 | |
| Overall Study | STARTED | Rituximab + Bendamustine | 227 | |
| Overall Study | COMPLETED | Tafasitamab + Bendamustine | 0 | |
| Overall Study | COMPLETED | Rituximab + Bendamustine | 0 | |
| Overall Study | NOT COMPLETED | Tafasitamab + Bendamustine | 226 | |
| Overall Study | NOT COMPLETED | Rituximab + Bendamustine | 227 |
Source ClinicalTrials.gov
Adverse events456
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 + Bendamustine | 31 | 219 | 41 |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab + Bendamustine | 15 | 225 | 16 |
| other | Alanine aminotransferase increased | Investigations | Tafasitamab + Bendamustine | 11 | 219 | 14 |
| other | Alanine aminotransferase increased | Investigations | Rituximab + Bendamustine | 10 | 225 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Tafasitamab + Bendamustine | 60 | 219 | 94 |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 48 | 225 | 73 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Tafasitamab + Bendamustine | 15 | 219 | 19 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Rituximab + Bendamustine | 11 | 225 | 11 |
| other | Aspartate aminotransferase increased | Investigations | Tafasitamab + Bendamustine | 12 | 219 | 15 |
| other | Aspartate aminotransferase increased | Investigations | Rituximab + Bendamustine | 8 | 225 | 13 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tafasitamab + Bendamustine | 129 | 226 |
| Total, all-cause mortality | Rituximab + Bendamustine | 127 | 227 |
| Total, other adverse events | Tafasitamab + Bendamustine | 206 | 219 |
| Total, other adverse events | Rituximab + Bendamustine | 199 | 225 |
| Total, serious adverse events | Tafasitamab + Bendamustine | 115 | 219 |
| Total, serious adverse events | Rituximab + Bendamustine | 100 | 225 |
Source ClinicalTrials.gov
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tafasitamab + Bendamustine vs Rituximab + Bendamustine: Number of Participants With Any Grade 3 or Higher TEAE | Trial comparisons |
| Tafasitamab + Bendamustine vs Rituximab + Bendamustine: deaths from any cause | Trial comparisons |
| Tafasitamab + Bendamustine vs Rituximab + Bendamustine: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Tafasitamab + Bendamustine vs Rituximab + Bendamustine: serious adverse events | Trial comparisons |
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/NCT02763319
GET https://conductscience.org/api/trials/v1/NCT02763319/registered?page=2