A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

Central Nervous System Lymphoma Clinical Trial

Official title: LCCC1841: A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

Status Recruiting

Clinical Trial Summary

The purpose of this study is to test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) lymphoma. Currently, there are no FDA-approved treatments for relapsed CNS lymphoma. Although acalabrutinib has not been approved for the treatment of CNS lymphoma, it was approved for the treatment of another type of lymphoma (mantle cell), by the Food and Drug Administration (FDA).

Acalabrutinib acts similar to another cancer drug called ibrutinib. lbrutinib was tested in several research trials for the management of CNS lymphomas, and the results were promising. Acalabrutinib and ibrutinib attack a similar target found in CNS lymphoma. Acalabrutinib may do a better job in attacking this target than ibrutinib. The study doctors will be looking to see if acalabrutinib can shrink cancer cells.

The participants will be given acalabrutinib and isavuconazole, because isavuconazole helps in preventing fungal infections that may occur during acalabrutinib treatment.

Clinical Trial Description

This multicenter open-label, single-arm, pilot study explores a safe and effective treatment for relapsed central nervous system lymphoma. The study investigates the antitumor effects and safety of acalabrutinib in subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) with no evidence of current systemic disease. Types of SCNSL included in the study are: Diffuse large B-cell lymphoma, mantle cell lymphoma, plasmablastic lymphoma, and lymphoplasmacytic lymphoma. Up to 16 subjects will be enrolled to attain a total of 15 evaluable subjects.

Duration of Therapy: Treatment with acalabrutinib and isavuconazole will continue unless

• Disease progression

• Inter-current illness that prevents further administration of treatment

• Unacceptable adverse event(s)

• Pregnancy

• Subject decides to withdraw from study treatment,

• General or specific changes in the subject's condition render the subject unacceptable for further treatment in the judgment of the investigator, or

• Subject is lost to follow up

Duration of Follow-up All subjects will be followed for survival for 5 years or until death, whichever occurs first. ;

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

• NCT number: NCT04548648
• Study type: Interventional
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Lynn Ruffin
• Phone: 9193081724
• Email: Lynn_ruffin@med.unc.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2020
• Completion date: February 22, 2033