Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus L… (NCT05328102) | Clinical Trial Compass
TerminatedPhase 2
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)
Stopped: The study has been terminated early by the sponsor due to business decision.
United States, France, Spain3 participantsStarted 2022-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
2
Part 1 A: Number of Participants With Cytokine Release Syndrome
Timeframe: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)