Acalabrutinib in CNSL

Central Nervous System Lymphoma Clinical Trial

Official title: A Phase 1/2 Study of Acalabrutinib in Recurrent or Refractory Central Nervous System Lymphoma (CNSL)

Status Recruiting

Clinical Trial Summary

This research study is a Phase 1/2 clinical trial testing the safety, tolerance and efficacy of the drug Acalabrutinib for people with recurrent or refractory central nervous system lymphoma (CNSL).

Clinical Trial Description

This is an open-label, dose-escalation phase 1/2 study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Acalabrutinib in patients with recurrent or refractory CNS lymphoma (R/R CNSL).

Acalabrutinib has been studied in lab experiments and in other types of cancer, and information from these studies suggests that acalabrutinib may be beneficial for people with recurrent or refractory central nervous system lymphoma (CNSL). Acalabrutinib targets a vulnerable part of cancer cells which leads to an inhibition of the growth of cancer cells.

The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for recurrent or refractory central nervous system lymphoma (CNSL) but it has been approved for other uses.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.

Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse.

Approximately 15 to 21 participants will be enrolled in phase1 and approximately 28 patients will be enrolled Phase 2.

AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, acalabrutinib. ;

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma
• Recurrence
• Recurrent Central Nervous System Lymphoma
• Refractory Central Nervous System Lymphoma

• NCT number: NCT04906902
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Lakshmi Nayak, MD
• Phone: 617-632-2166
• Email: Lakshmi_Nayak@dfci.harvard.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 23, 2021
• Completion date: January 31, 2026