Duke logo

Incyte INCB 50465-204_MZL_McKinney - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how well INCB050465 works in patients with marginal zone lymphoma (MZL) that is relapsed or refractory after at least 1 systemic treatment regimen.

What is the Condition Being Studied?

Relapsed or refractory marginal zone lymphoma (MZL) with or without prior exposure to a BTK inhibitor

Who Can Participate in the Study?

Adults with marginal zone lymphoma (MZL) that is relapsed or has not responded to treatment and who:
- Have previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody
- Have measurable disease at least 1 lesion larger than 1.5 cm as assessed by CT
- Have not had any prior treatment with idelalisib or other PI3K inhibitor
- Don't have active graft versus host disease
- Don't have liver disease, Hepatitis B or C infection or risk of reactivation

Age Group
Adults

What is Involved?

If you choose to join the study:
- You will have a screening visit that will include questions, physical examination, blood work, bone marrow biopsy, CT scans, and ECGs.
- Once your eligibility is confirmed you will be randomly assigned (like the flip of a coin) to one of two groups that will get different doses of INCB050465, which will be taken by mouth every day in 8 week cycles.

Your study doctor will tell you what dose you will receive.

You will come back to the clinic every 4 weeks to:
- Get a new package of tablets
- Have a physical examination
- Answer questions about your medications and how you are doing,
- Have ECGs before you receive your dose and 1.5 hrs after your dose
- Have CT scans (every 8 weeks)
- Have a bone marrow biopsy (every 8 weeks) to confirm response if the bone marrow biopsy was positive during screening.
- Follow up at end of treatment, 30-35 days later, and then every 12 weeks.

Study Details

Full Title
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00085229
NCT:NCT03144674
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698