Study on Ibrutinib for Treating Patients with Relapsed or Hard-to-Treat Follicular Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01849263
This clinical trial is testing how well the drug ibrutinib works for patients with follicular lymphoma that has returned after treatment or hasn't responded to previous therapies. Ibrutinib may help by blocking certain enzymes that cancer cells need to grow.
Patient Parameters
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Program Overview
The main goal of this study is to see how effective ibrutinib is in treating patients with follicular lymphoma that has come back or is not responding to treatment. Researchers will also look at the safety of ibrutinib and how well patients tolerate it. They will measure how long patients live, how quickly they respond to treatment, and how long the response lasts. Additionally, the study will explore how ibrutinib affects certain cancer-related molecules in the blood and how it interacts with specific genetic mutations in the cancer.
Description
In this study, patients will take ibrutinib by mouth once a day in 28-day cycles. They will continue taking the medication as long as it is effective and does not cause unacceptable side effects. If the cancer progresses after two cycles, patients may continue treatment until the end of the fifth cycle, depending on their doctor's decision. After finishing the treatment, patients will have follow-up visits every three months until the cancer progresses, and then every six months for up to five years. The study will also collect tissue and blood samples for future research.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with follicular lymphoma, grades 1, 2, or 3a.
- Have a tumor biopsy available or be willing to undergo a biopsy.
- Have a measurable tumor that is at least 1.5 cm in size.
- The lymphoma has returned or not responded after at least one previous chemotherapy treatment.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test before joining the study.
- Be able to understand and sign a consent form.
- Agree to provide biological samples for research purposes.
Exclusion Criteria
- Recent chemotherapy, radiotherapy, or surgery within specified timeframes before joining the study.
- Previous treatment with ibrutinib or similar drugs.
- Active involvement of the central nervous system by lymphoma.
- Taking medications that strongly affect liver enzymes CYP3A4/5.
- Pregnant or breastfeeding women, or those not using effective contraception.
- HIV-positive patients on certain antiretroviral therapies.
- Active hepatitis B or C infection.
- History of transformation to a more aggressive lymphoma type.
- Recent history of stroke or brain bleeding.
- Need for blood thinners like warfarin.
- Difficulty swallowing tablets.
- Uncontrolled illnesses such as infections, diabetes, heart disease, or psychiatric conditions.
- Another active cancer, except for certain skin cancers.
- Allergic reactions to similar drugs.
- Use of high-dose steroids recently.
- Previous stem cell transplant from a donor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Metro Minnesota Community Oncology Research Consortium | 55416 | Saint Louis Park | Minnesota |
| Park Nicollet Clinic - Saint Louis Park | 55416 | Saint Louis Park | Minnesota |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| University of Wisconsin Carbone Cancer Center - University Hospital | 53792 | Madison | Wisconsin |
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