Extended Ibrutinib Treatment for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Pharmacyclics Switzerland GmbH

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial provides continued access to ibrutinib for patients who benefited from previous studies and cannot buy it locally. Ibrutinib is an oral medication that stops cancer cells from growing by blocking a protein they need. It is used in the treatment of chronic lymphocytic leukemia and has been studied for its effectiveness in relapsed CLL and as frontline therapy.

Eligibility Criteria

This trial is for patients already in an ibrutinib study who've seen benefits but can't get the drug commercially. They must have finished all previous study requirements, agree to birth control methods, and not be pregnant or planning pregnancy.

Inclusion Criteria

Subject must have participated in an eligible ibrutinib clinical trial and may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician

I am currently on continuous treatment with ibrutinib.

I have finished all tests in my current treatment plan and wish to keep taking ibrutinib.

+3 more

Exclusion Criteria

I am willing and able to follow all study requirements.

Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol

I plan to try for a child during or within 3 months after the study.

+3 more

Participant Groups

The trial provides ongoing access to ibrutinib for those benefiting from it after completing prior studies. It's open-label and multicenter, meaning both doctors and participants know they're getting ibrutinib, at various locations.

1Treatment groups

Experimental Treatment

Group I: IbrutinibExperimental Treatment1 Intervention

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.