Trial · NCT05328102
Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)
NCT05328102, Phase 2, Terminated, Xencor, Inc.; results first posted 2024-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL). Trials, record NCT05328102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05328102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)
- NCT number
- NCT05328102
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Xencor, Inc.
- Conditions
- Diffuse Large-cell B-cell Lymphoma
- Interventions
- Plamotamab, Tafasitamab, Lenalidomide
- First posted
- 2022-04-14
- Last updated
- 2024-04-30
- Results first posted
- 2024-04-30
- Limitations and caveats
Due to the early termination of the study in Part 1A, only 3 participants enrolled. No participants were enrolled in Part 1B or Part 2. Safety data is limited due to the small sample size. No efficacy data was collected for the secondary outcome measures.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) | An adverse event (AE) was any untoward medical occurrence in a study participant. The AE did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug. AEs may have included the onset of new illness and the exacerbation of preexisting conditions. TEAEs were defined as events with onset dates on or after the start of study treatment or events that were present before the first infusion of study treatment and subsequently worsened in severity. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Primary | Part 1 A: Number of Participants With Cytokine Release Syndrome | From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) | Cytokine release syndrome was defined as "a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells". A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) | Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 A: Number of Participants With Cytokine Release Syndrome | From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) | Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 | Participants | ||
| Part 1 A: Number of Participants With Cytokine Release Syndrome | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 2 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 | |
| Overall Study | COMPLETED | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 0 | |
| Overall Study | NOT COMPLETED | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 |
Source ClinicalTrials.gov
Adverse events50
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 | Cytokine release syndrome | Immune system disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 2 | 3 | |
| other | Fatigue | General disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 2 | 3 | |
| other | Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Skin irritation | Skin and subcutaneous tissue disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Oedema peripheral | General disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Hypervolaemia | Metabolism and nutrition disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Rash | Skin and subcutaneous tissue disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 2 | 3 | |
| other | Blood creatinine increased | Investigations | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 | |
| other | Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 1 | 3 |
| Total, other adverse events | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 | 3 |
| Total, serious adverse events | Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide | 3 | 3 |
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 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/NCT05328102
GET https://conductscience.org/api/trials/v1/NCT05328102/events?page=2