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.
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
Inter-current illness that prevents further administration of treatment
Unacceptable adverse event(s)
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.