Plamotamab, Tafasitamab and Lenalidomide Vs Tafasitamab and Lenalidomide in R/RDLBCL lymphoma
Research type
Research Study
Full title
A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb®13676 (Plamotamab) Combined with Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
IRAS ID
1005710
Contact name
Sunil Iyengar
Contact email
Sponsor organisation
Xencor, Inc.
Eudract number
2021-003658-22
Research summary
The purpose of this study is to learn about the safety and effectiveness of an investigational drug, XmAb®13676 (plamotamab), which will be given in combination with two approved products, tafasitamab and lenalidomide, to see if the addition of plamotamab will delay the worsening of diffuse large B-cell lymphoma (DLBCL). Plamotamab given in combination with tafasitamab and lenalidomide will be compared to using tafasitamab and lenalidomide alone. Participants will receive study treatment until their disease worsens, they experience unacceptable side effects (toxicity), or they start a new treatment and will remain in the study for up to 5 years. Approximately 240 participants will take part in the study, with up to 120 research sites in multiple countries. The study is divided into two parts, Part 1 and Part 2. Participants will be enrolled in either Part 1 or Part 2 of the study, depending on the stage that the study is in at the time of enrolment. Participants in Part 1 will receive the plamotamab in combination with tafasitamab and lenalidomide, in two groups receiving different doses of plamotamab. The results of Part 1 will determine which dose will be given to the participants in Part 2. In Part 2, Participants will receive plamotamab at the dose that was determined by the results of Part 1 of the study, in combination with tafasitamab and lenalidomide or they will not receive plamotamab and only receive tafasitamab and lenalidomide. Participation will including physical examinations, vital sign measurements, neurological testing, blood and urine sample collection, tumour biopsy, ECG, PET/CT scans, and other procedures and tests.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0136
Date of REC Opinion
17 Oct 2022
REC opinion
Further Information Favourable Opinion