NCT04337827

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

Phase II Study of Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder (PTLD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Deepa Jagadeesh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-randomized phase II study of acalabrutinib plus rituximab in newly diagnosed B-cell PTLD in participants with both solid organ transplant (SOT) and Bone marrow transplant (BMT). Acalabrutinib is an inhibitor of Bruton Tyrosine Kinase (BTK). BTK is important in B cells and plays a role in the development of PTLD. Acalabrutinib is approved in the US for the treatment of adult participants with indolent lymphoma, mantle cell lymphoma, and is being evaluated to treat other lymphomas. Rituximab has been approved for treatment of B cell non-Hodgkin lymphoma (NHL). While not approved for PTLD, it has become the mainstay of treatment. The primary objective of this study is to determine the overall response rate to combination treatment with rituximab and acalabrutinib in patients with PTLD. The secondary objectives of this study is to determine response rates, survival, failure rates, and safety elements in participants with PTLD treated with combination rituximab and acalabrutinib.

Conditions

• Post-transplant Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	Rituximab	Weekly x 4 weeks. If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto Long Term Follow Up (LTFU).
DRUG	Acalabrutinib	100mg twice per day (BID) x 4 weeks (28 day cycle) If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto LTFU.
DIAGNOSTIC_TEST	CT scans	2 weeks (day 36 ± 5 days) after end of cycle 1 treatment.

Timeline

• Start date: 2020-09-02
• Primary completion: 2022-06-27
• Completion: 2022-12-19
• First posted: 2020-04-08
• Last updated: 2024-04-10
• Results posted: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study