Study Details

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Study of Acalabrutinib in Relapsed/Refractory CNS Lymphomas

The purpose of this study is to test whether giving the study drug acalabrutinib is safe and could help control B-cell Non-Hodgkin CNS lymphoma that have not gone away, or have come back, after the first round of treatment.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study drug, acalabrutinib, will be dispensed in pill form to the patient and is to be taken twice daily. Isavuconazole, an anti-fungal, whill be perscribed to prevent any fungal infections and will be taken twice daily while taking study drug. There will be a drug diary that is to be filled out daily documenting the time study drug was taken and any symptoms the patient may be experiencing that day. Throughout the trial you will undergo exams to monitor your health status such as blood tests, physical exams, eye exams, a tumor biopsy, a spinal tap to collect cerebrospinal fluid collections and brain MRIs. There will also be questionnaires that you are asked to fill out throughout the trial.

Incentives

Neither you, nor your insurance will need to pay for the study drug acalabrutinib.

In-person visits:
10

Total length of participation:
8 months treatment and 5 years follow up

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with B-cell Non-Hodgkin CNS lymphoma
You have received at least one prior treatment of chemotherapy to treast you disease
Adequate organ function
Able to take Isavuconazole

Not eligible if:

You are currently participating in another clinical trial, are taking an experimental drug or are currently receiving chemotherapy
Prior brain radiotherapy
You have a history of HIV, Hepatitis B or Hepatitis C infections, or are diagnosed with a uncontrolled active infection
Have severe liver, heart or bleeding problems
Has familial short QT syndrome

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Christopher Dittus
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

19-3321

ClinicalTrials.gov

NCT04548648