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We are delighted to welcome the former Lake Norman Regional Medical Center (LNRMC) in Mooresville, NC into the Duke Health family as Duke Health Lake Norman Hospital!

Curis CA-4948-101 (Primary Central Nervous System Lymphoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called CA-4948 is a safe and effective option for people with PCNSL. We want to know how well it works when it is combined with a drug called ibrutinib, which is commonly used to treat PCNSL.

What is the Condition Being Studied?

Primary Central Nervous System Lymphoma (PCNSL)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with PCNSL by biopsy or imaging
  • Have disease that worsened or came back after standard therapy
  • Have a life expectancy of more than 3 months

For more information, contact the study team at 919-684-5301.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:

  • Take the study drug tablets by mouth twice daily
  • Take ibrutinib tablets by mouth once a day (preferably in the morning)
  • Have physical exams and blood tests
  • Have heart images taken
  • Have electrocardiograms (ECGs)
  • Have CT/MRI scans
  • Have eye examinations
  • Have a lumbar puncture (spinal tap)

You will have assessments of how you are doing with the study drug regimen at the end of every "cycle." A cycle is a 28-day period in which you will take the study drug and ibrutinib. The number of cycles you do in the study will depend on how well you respond to the study drug regimen. You can continue for as long as you and your study doctor believe that you are receiving a positive benefit.

Study Details

Full Title
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
Principal Investigator
Protocol Number
IRB: PRO00115450
NCT: NCT03328078
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate