Ibrutinib + Rituximab + Lenalidomide for Central Nervous System Lymphoma

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byChristian Grommes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The investigator's want to find out if treatment with ibrutinib, rituximab, and lenalidomide are safe and better than the usual approach in patients with recurrent or refractory central nervous system lymphoma.

Eligibility Criteria

Adults with recurrent or refractory primary or secondary central nervous system lymphoma who have had at least one prior CNS therapy can join. They must be able to undergo MRI/CT scans, sign consent, and meet specific health criteria like adequate organ function and blood counts. Women of childbearing age need a negative pregnancy test and agree to birth control measures.

Inclusion Criteria

My cancer is confirmed as PCNSL or DLBCL through tissue examination.

I am able to get out of my bed or chair and move around.

My bone marrow and organs are functioning well.

+6 more

Exclusion Criteria

I have had a stem cell transplant from a donor.

I am currently taking medication that affects liver enzyme CYP3A.

I am currently on medication that suppresses my immune system.

+21 more

Participant Groups

The trial is testing the safety and effectiveness of combining three drugs: Ibrutinib, Rituximab, and Lenalidomide for patients with certain types of brain lymphomas that haven't responded well to previous treatments. The goal is to see if this combination works better than standard approaches.

1Treatment groups

Experimental Treatment

Group I: ibrutinib in combination with rituximab and lenalidomideExperimental Treatment3 Interventions

Ibrutinib will be given day 1-28; Lenalidomide will be given day 1-21; Rituximab will be given on day 1. Rituximab is given for 6 cycles; Lenalidomide is given for 12 cycles; Ibrutinib is continued until disease progression, intolerable toxicity or death.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: