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

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

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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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Katherine
Peters

Protocol Number

PRO00115450

NCT ID

NCT03328078

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov