Ibrutinib for Relapsed or Refractory Follicular Lymphoma

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4/5 inhibitors

Disqualifiers: CNS involvement, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 courses (20 weeks)

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ibrutinib works in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Research Team

Nancy L Bartlett

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with relapsed or unresponsive follicular lymphoma, who've had at least one prior treatment. They must have measurable disease, acceptable blood counts and organ function, and be willing to provide samples for research. Pregnant women, those on certain drugs like CYP3A4/5 inhibitors or steroids, HIV-positive patients on antiretroviral therapy, individuals with active hepatitis B/C or other serious health issues are excluded.

Inclusion Criteria

My lymphoma is confirmed as follicular, grades 1, 2, or 3a.

I have a tumor or lymph node that is at least 1.5 cm big.

Absolute neutrophil count >= 750/mm^3 (0.75 x 10^9/L)

Exclusion Criteria

I haven't had chemotherapy or systemic therapy in the last 4 weeks.

I have not had a stroke or brain bleed in the last 6 months.

I need blood thinners like warfarin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ibrutinib orally once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 5 courses (20 weeks)

Monthly visits for each course

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 3 months until progressive disease, then every 6 months for 5 years.

5 years

Quarterly visits initially, then biannual visits

Treatment Details

Interventions

• Ibrutinib

Trial Overview The trial tests Ibrutinib's effectiveness in treating follicular lymphoma that has returned after treatment or hasn't responded to previous treatments. It involves taking Ibrutinib pills which may block enzymes that cancer cells need to grow.

Participant Groups

Group I: Treatment (ibrutinib) Experimental Treatment 2 Interventions

Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.

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

Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+