Trial · NCT05222555
Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
NCT05222555, Phase 1, Phase 2, Active not recruiting, Incyte Corporation; results first posted 2025-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients. Trials, record NCT05222555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05222555
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
- NCT number
- NCT05222555
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Tafasitamab, Lenalidomide
- First posted
- 2022-02-03
- Last updated
- 2026-01-16
- Other registries' IDs
- eudract:2021-003855-40
- Results first posted
- 2025-07-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 2 years | An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE. |
| Primary | Number of Participants With Any ≥Grade 3 TEAE | up to approximately 2 years | The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. |
| Secondary | Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles]) | Ctrough was defined as the minimum concentration of tafasitamab. |
| Secondary | Cmax of Tafasitamab After 3 Treatment Cycles | 30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles]) | Cmax was defined as the maximum observed plasma concentration of tafasitamab. |
| Secondary | Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12 | up to 19.8 months | ORR was defined as the percentage of participants with complete response (CR: disappearance of all evidence disease) or partial response (PR: regression of measurable disease and no new sites) as the best response achieved at any time during the study. Only responses of CR or PR that were documented before the initiation of new antilymphoma therapy (NALT) were considered. Response assessments were based on revised International Working Group response criteria for malignant lymphoma. |
| Secondary | Duration of Response (DoR) by Investigator Assessment | up to approximately 64 months (approximately 5 years) | |
| Secondary | Progression-free Survival (PFS) by Investigator Assessment | up to approximately 64 months (approximately 5 years) | |
| Secondary | Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12 | up to approximately 1 year (after twelve 28-day cycles) | Anti-tafasitamab antibody samples were defined as negative if they were screened or confirmed negative. Anti-tafasitamab antibody samples were defined as positive if they were positive in both the screening and the confirmatory assays. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 2 years | Safety Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 postbaseline safety assessment. A valid safety assessment included death. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any ≥Grade 3 TEAE | up to approximately 2 years | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles]) | Pharmacokinetic Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 quantifiable serum tafasitamab concentration. Only participants with available data were analyzed. | micrograms per milliliter (μg/mL) | MEAN |
| SECONDARY | Cmax of Tafasitamab After 3 Treatment Cycles | 30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles]) | Pharmacokinetic Analysis Set. Only participants with available data were analyzed. | micrograms per milliliter (μg/mL) | MEAN |
| SECONDARY | Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12 | up to 19.8 months | Full Analysis Set: all participants who received at least 1 dose of study treatment. Participants were analyzed according to the dose group to which they were initially assigned. Confidence intervals were calculated based on the Clopper-Pearson exact method for binomial distributions. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) by Investigator Assessment | up to approximately 64 months (approximately 5 years) | |||
| SECONDARY | Progression-free Survival (PFS) by Investigator Assessment | up to approximately 64 months (approximately 5 years) | |||
| SECONDARY | Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12 | up to approximately 1 year (after twelve 28-day cycles) | Immunogenicity Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 valid anti-tafasitamab antibody assessment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 6 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 45 | Participants | ||
| Number of Participants With Any ≥Grade 3 TEAE | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 5 | Participants | ||
| Number of Participants With Any ≥Grade 3 TEAE | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 38 | Participants | ||
| Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Cycle 3 Day 15 | 170 | Standard Deviation 117 | micrograms per milliliter (μg/mL) |
| Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Cycle 3 Day 15 | 228 | Standard Deviation 102 | micrograms per milliliter (μg/mL) |
| Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Cycle 12 Day 28 | 87 | Standard Deviation 26 | micrograms per milliliter (μg/mL) |
| Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Cycle 12 Day 28 | 149 | Standard Deviation 69 | micrograms per milliliter (μg/mL) |
| Cmax of Tafasitamab After 3 Treatment Cycles | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 792 | Standard Deviation 420 | micrograms per milliliter (μg/mL) | |
| Cmax of Tafasitamab After 3 Treatment Cycles | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 797 | Standard Deviation 273 | micrograms per milliliter (μg/mL) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 Dose Level 1 + 25 mg Lenalidomide | 6 | |
| Overall Study | STARTED | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 47 | |
| Overall Study | COMPLETED | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 3 | |
| Overall Study | COMPLETED | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 11 | |
| Overall Study | NOT COMPLETED | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 3 | |
| Overall Study | NOT COMPLETED | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 36 |
Source ClinicalTrials.gov
Adverse events240
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 | Alanine aminotransferase increased | Investigations | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 1 | 6 | 2 |
| other | Alanine aminotransferase increased | Investigations | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 2 | 47 | 2 |
| other | Alanine aminotransferase increased | Investigations | Total | 3 | 53 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 2 | 6 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 9 | 47 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 11 | 53 | 16 |
| other | Anxiety | Psychiatric disorders | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 1 | 6 | 1 |
| other | Anxiety | Psychiatric disorders | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 1 | 47 | 1 |
| other | Anxiety | Psychiatric disorders | Total | 2 | 53 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 0 | 6 | 0 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 1 | 6 |
| Total, all-cause mortality | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 8 | 47 |
| Total, all-cause mortality | Total | 9 | 53 |
| Total, other adverse events | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 6 | 6 |
| Total, other adverse events | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 40 | 47 |
| Total, other adverse events | Total | 46 | 53 |
| Total, serious adverse events | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | 2 | 6 |
| Total, serious adverse events | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 20 | 47 |
| Total, serious adverse events | Total | 22 | 53 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any ≥Grade 3 TEAE | Trial comparisons |
| Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12 | 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/NCT05222555
GET https://conductscience.org/api/trials/v1/NCT05222555/events?page=2