Active — Not RecruitingPhase 2

Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma

United States40 participantsStarted 2021-02-24

Plain-language summary

This phase II trial studies how well obinutuzumab, ibrutinib, and venetoclax work in treating patients with previously untreated stage II-IV follicular lymphoma. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib and venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab, ibrutinib, and venetoclax together may work better in treating follicular lymphoma compared to each drug alone.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated * Able and willing to provide written informed consent and to comply with the study protocol * Bi-dimensionally measurable disease, with at least one mass lesion \>= 2 cm in longest diameter by CT, PET/CT, and/or magnetic resonance imaging (MRI) * Must be in need of therapy as evidenced by at least one of the following criteria: * Bulky disease defined as: * A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter or, * At least 3 nodal or extranodal sites \>= 3 cm in diameter * Presence of at least one B symptom: * Fever (\> 38 Celsius \[C\]) not due to infectious etiology * Night sweats * Weight loss \> 10% in the past 6 months * Fatigue due to lymphoma * Splenomegaly (\> 13 cm) * Compression syndrome (ureteral, orbital, gastrointestinal) * Any of the following cytopenias, due to lymphoma: * Hemoglobin =\< 10 g/dL * Platelets =\< 100 x 10\^9/L * Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L * Pleural or peritoneal effusion * Lactate dehydrogenase (LDH) \> upper limit of normal (ULN) or beta (B)2 microglobulin \> ULN * Other lymphoma-mediated symptoms as determined by the treating physician * Stage II, III, or IV disease * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count (ANC) \> 1.0 x 10\^9/L * Platelet count \> 50 x 10\^9/L * Prothrombin time (PT)/international norm…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete response (CR) rate

Timeframe: At 12 months

Trial details

NCT IDNCT04450173

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Ann Arbor Stage II Follicular Lymphoma trials