A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB) (NCT04138875) | Clinical Trial Compass
WithdrawnPhase 2
A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
Stopped: Lack of funding
United States0Started 2022-01
Plain-language summary
This is an open label, risk-stratified, sequential treatment, phase 2 study of newly diagnosed post-transplant lymphoproliferative disorders with positive CD20 and CD30 expression. It includes an induction phase with rituximab and brentuximab vedotin (RBv), followed by a treatment phase with RBv or RBv in combination with bendamustine (RBvB) based on response to induction.
The primary end point is treatment efficacy measured as the overall response rate (ORR) and progression free survival (PFS).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and ≤ 70 at the time of signing informed consent
✓. Patient must have histologically confirmed newly diagnosed polymorphic or monomorphic PTLD defined according to the 2016 World Health Organization (WHO) classification criteria.
✓. Diagnostic archival tissue available for review and correlative studies
✓. Previous solid organ or allogeneic hematopoietic stem cell transplant
✓. Measurable disease
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
✓. Patients must have adequate organ and marrow function
✓. Negative urine or serum pregnancy test for women of childbearing potential
Exclusion criteria
✕. Previous treatment for PTLD with the exception of immunosuppression reduction