drugset / Trial / NCT04337827

Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder

NCT04337827

Phase 2 Terminated 6 enrolled Deepa Jagadeesh
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Rituximab alone is commonly used and works in some cases, but not others. In addition, participants with PTLD have trouble tolerating therapies with large amounts of side effects due to their health conditions and medications for their transplant. Due to these reasons the study team is looking for a new treatment with novel targeted agents in order to improve outcomes and to minimize toxicity. Based on emerging data of clinical efficacy of acalabrutinib in B cell malignancies and an unmet need for novel therapies in PTLD, this study will investigate the use of rituximab and acalabrutinib in participants with newly diagnosed B cell PTLD.

Timeline

Start
2020-09-02
Primary completion
2022-06-27
Completion
2022-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule 100 mg
Subject Rituximab Monoclonal antibody