Diffuse Large-cell B-cell LymphomaPhase 2NCT05328102
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)
A Phase 2 study testing Plamotamab, Tafasitamab and Lenalidomide in people with Diffuse Large-cell B-cell Lymphoma, run by Xencor, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large-cell B-cell Lymphoma
- What is being tested?
- Plamotamab, Tafasitamab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Apr 2022to 21 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of DLBCL, not otherwise specified, including DLBCL arising from low grade lymphoma
- CD20+ and CD19+ lymphoma
- Archival paraffin embedded tumor tissue or unstained slides must be available for retrospective cell of origin determination
- Relapsed or refractory
- At least 1 prior systemic line(s) of therapy, one of which must have included multi-agent chemoimmunotherapy that includes an anti-CD20 monoclonal antibody.
- At least 1 bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of ≥ 1.5 centimeter (cm) and greatest perpendicular diameter of ≥ 1.0 cm at baseline. The lesion must have a positive finding on positron emission tomography (PET) scan
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- Ineligible for or refuse hematopoietic stem cell transplantation (HSCT).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Completed vaccination for the SARS-CoV-2 virus prior to study entry
- Fertile participants must agree to use 2 highly effective methods of birth control during for at least 6 months (male participants) and 8 months (female participants) after the last dose of study treatment
Who cannot join
- Any other histological type of lymphoma, including high-grade B-cell lymphoma, including those with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements primary mediastinal (thymic) large B cell (PMBL) or Burkitt lymphoma
- A prior diagnosis of chronic lymphocytic leukemia (CLL) (Richter's Transformation)
- Primary central nervous system lymphoma
- Exclusionary Previous and Current Treatment:
- Previously received treatment with an anti-CD20 × anti-CD3 bispecific antibody (bsAb)
- Anti-CD20 therapy (for example, rituximab) within 21 days prior to study entry
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- Participants who have, within 14 days prior study entry:
- Chemotherapy, radiotherapy, or other lymphoma-specific therapy not including anti CD20 therapy
- Small molecule or investigational anticancer agents within 6 elimination half-lives
- Received live vaccines within 30 days
- Required systemic anti-infective therapy for active, intercurrent infections
- Participants who have had the following prior therapies or treatments:
- Were previously treated with CD19-targeted therapy, including chimeric antigen receptor-T cell (CAR-T), unless current biopsy is CD19+
- Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory imide drugs (IMiDs)
- Previous allogenic stem cell transplantation
- Have a history of deep venous thrombosis/embolism, threatening thromboembolism
- Concurrently use other anticancer or experimental treatments
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.
Read the detailed description
This is a randomized, multicenter, open-label, Phase 2 study of plamotamab combined with tafasitamab plus lenalidomide versus tafasitamab plus lenalidomide in adult participants with DLBCL who have relapsed after or are refractory to at least 1 prior line of therapy, which must have included multi-agent chemoimmunotherapy inclusive of an anti-cluster of differentiation (CD) 20 monoclonal antibody, and who are not candidates for autologous stem-cell transplantation (ASCT), refuse ASCT, or relapse after ASCT.
The study was planned to be performed sequentially, with Part 1A (Safety run-in, with a lower plamotamab dose), Part 1B (Safety run-in, with the target plamotamab dose) and Part 2 (Open-Label, randomized). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
- Conditions
- Diffuse Large-cell B-cell Lymphoma
- Being tested
- Plamotamab, Tafasitamab, Lenalidomide
- Keywords
- DLBCL, NOS, Diffuse Large B-cell Lymphoma, Transformed indolent Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlamotamabBiological
Also called XmAb13676
Biological
TafasitamabBiological
Biological
LenalidomideDrug
Drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide | Experimental | Drug: Plamotamab will be administered at a lower dose in addition to tafasitamab (12 milligrams [mg]/kilograms [kg] intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially prior to Part 1B. Receives: Biological: Plamotamab; Biological: Tafasitamab; Drug: Lenalidomide |
| Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide | Experimental | Drug: Plamotamab will be administered at the target dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially after Part 1A. Receives: Biological: Plamotamab; Biological: Tafasitamab; Drug: Lenalidomide |
| Part 2A :Plamotamab, Tafasitamab, and Lenalidomide | Experimental | Drug: Plamotamab will be administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally). Receives: Biological: Plamotamab; Biological: Tafasitamab; Drug: Lenalidomide |
| Part 2B: Tafasitamab and Lenalidomide | Active comparator | Drug: Tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally). Receives: Biological: Tafasitamab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Measured: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Part 1 A: Number of Participants With Cytokine Release Syndrome
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.
Measured: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Apr 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Why it stopped: The study has been terminated early by the sponsor due to business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large-cell B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Part 1 Single Arm Multiple Dose Followed by Part 2 Randomized
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Chiarella, Study director, Senior Director, Clinical Science, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328102
- Sponsor's protocol ID
- XmAb13676-03
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2022
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05328102
- Acronym / sponsor ID
- XmAb13676-03
- Conditions
- Diffuse Large-cell B-cell Lymphoma
- Keywords
- DLBCL, NOS, Diffuse Large B-cell Lymphoma, Transformed indolent Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated early by the sponsor due to business decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.
Detailed description
This is a randomized, multicenter, open-label, Phase 2 study of plamotamab combined with tafasitamab plus lenalidomide versus tafasitamab plus lenalidomide in adult participants with DLBCL who have relapsed after or are refractory to at least 1 prior line of therapy, which must have included multi-agent chemoimmunotherapy inclusive of an anti-cluster of differentiation (CD) 20 monoclonal antibody, and who are not candidates for autologous stem-cell transplantation (ASCT), refuse ASCT, or relapse after ASCT.
The study was planned to be performed sequentially, with Part 1A (Safety run-in, with a lower plamotamab dose), Part 1B (Safety run-in, with the target plamotamab dose) and Part 2 (Open-Label, randomized). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part 1 Single Arm Multiple Dose Followed by Part 2 Randomized
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide | Experimental | Biological: Plamotamab, Biological: Tafasitamab, Drug: LenalidomideDrug: Plamotamab will be administered at a lower dose in addition to tafasitamab (12 milligrams [mg]/kilograms [kg] intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially prior to Part 1B. |
| Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide | Experimental | Biological: Plamotamab, Biological: Tafasitamab, Drug: LenalidomideDrug: Plamotamab will be administered at the target dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially after Part 1A. |
| Part 2A :Plamotamab, Tafasitamab, and Lenalidomide | Experimental | Biological: Plamotamab, Biological: Tafasitamab, Drug: LenalidomideDrug: Plamotamab will be administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally). |
| Part 2B: Tafasitamab and Lenalidomide | Active comparator | Biological: Tafasitamab, Drug: LenalidomideDrug: Tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diagnosis of DLBCL, not otherwise specified, including DLBCL arising from low grade lymphoma
- CD20+ and CD19+ lymphoma
- Archival paraffin embedded tumor tissue or unstained slides must be available for retrospective cell of origin determination
- Relapsed or refractory
- At least 1 prior systemic line(s) of therapy, one of which must have included multi-agent chemoimmunotherapy that includes an anti-CD20 monoclonal antibody.
Key exclusion criteria (17 listed)
- Any other histological type of lymphoma, including high-grade B-cell lymphoma, including those with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements primary mediastinal (thymic) large B cell (PMBL) or Burkitt lymphoma
- A prior diagnosis of chronic lymphocytic leukemia (CLL) (Richter's Transformation)
- Primary central nervous system lymphoma
- Previously received treatment with an anti-CD20 × anti-CD3 bispecific antibody (bsAb)
- Anti-CD20 therapy (for example, rituximab) within 21 days prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlamotamabAlso: XmAb13676Biological | Biological | Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide, Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide, Part 2A :Plamotamab, Tafasitamab, and Lenalidomide |
| TafasitamabBiological | Biological | Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide, Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide, Part 2A :Plamotamab, Tafasitamab, and Lenalidomide, Part 2B: Tafasitamab and Lenalidomide |
| LenalidomideDrug | Drug | Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide, Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide, Part 2A :Plamotamab, Tafasitamab, and Lenalidomide, Part 2B: Tafasitamab and Lenalidomide |
Primary outcome
Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 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.
Part 1 A: Number of Participants With Cytokine Release Syndrome
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chiarella study director
Senior Director, Clinical Science, Clinical Development
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plamotamab, Tafasitamab and Lenalidomide in people with Diffuse Large-cell B-cell Lymphoma, run by Xencor, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.