Study on Obinutuzumab, Ibrutinib, and Venetoclax for Treating Untreated Stage II-IV Follicular Lymphoma

Sponsor: Joseph Tuscano

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04450173

Provider View

This clinical trial is testing a combination of three drugs—obinutuzumab, ibrutinib, and venetoclax—to see how well they work together in treating patients with stage II-IV follicular lymphoma who have not received treatment before.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—obinutuzumab, ibrutinib, and venetoclax—works in treating patients with stage II-IV follicular lymphoma who have not been treated before. Obinutuzumab is an immunotherapy that may help the immune system fight cancer, while ibrutinib and venetoclax may stop cancer cells from growing. The study aims to find out if using these drugs together is more effective than using each one alone.

Description

The main goal of this study is to see how effective the combination of obinutuzumab, venetoclax, and ibrutinib is in treating follicular lymphoma that hasn't been treated before. Researchers will look at how many patients have no signs of cancer after 12 months of treatment. They will also check the safety of this drug combination by monitoring any side effects and how severe they are.

Patients in the study will receive obinutuzumab through an IV on specific days during the first cycle and then on the first day of several following cycles. They will also take venetoclax and ibrutinib pills daily. This treatment will continue for up to 24 cycles, as long as the cancer doesn't get worse and the side effects are manageable.

After finishing the treatment, patients will have follow-up visits for up to two years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with follicular lymphoma (grades 1, 2, or 3a) that hasn't been treated yet.
  • Willing to provide written consent and follow the study procedures.
  • Have a measurable tumor that is at least 2 cm in size.
  • Need treatment due to symptoms like large tumors, fever, night sweats, weight loss, fatigue, or other specific conditions related to lymphoma.
  • Have stage II, III, or IV disease.
  • Be in good general health with a performance status of 0 to 2.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing age and men must use reliable birth control during the study and for a period after the study ends.
  • Women must have a negative pregnancy test before starting the study.
  • Agree to participate and understand the study's purpose and procedures.

Exclusion Criteria

  • Have active lymphoma in the central nervous system or certain other types of lymphoma.
  • Have had another type of cancer in the past 5 years, unless it's a non-threatening type like certain skin cancers.
  • Have severe allergies to monoclonal antibody therapy.
  • Have certain infections like active hepatitis or HIV.
  • Have significant heart disease or abnormal heart rhythms.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have had major surgery recently or received certain vaccines within the past month.
  • Have bleeding disorders or a history of stroke.
  • Are unable to follow the study procedures or understand the study's purpose.

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