Study on Obinutuzumab and Ibrutinib as Initial Treatment for Patients with Slow-Growing Non-Hodgkin's Lymphomas

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03198026

Provider View

This clinical trial is exploring how well the combination of obinutuzumab and ibrutinib works as a first treatment for patients with slow-growing types of non-Hodgkin's lymphoma. These drugs may help stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is testing the effectiveness of two drugs, obinutuzumab and ibrutinib, as a first treatment for patients with slow-growing non-Hodgkin's lymphoma. Obinutuzumab is a type of antibody that may block cancer cell growth, while ibrutinib may stop cancer cells by blocking certain enzymes they need to grow. The study aims to see if using these drugs together is more effective than other treatments.

Description

The main goal of this study is to see how well the combination of ibrutinib and obinutuzumab works in patients who have not received chemotherapy for their slow-growing lymphomas. Researchers will also look at how long patients live without the disease getting worse and overall survival rates. They will assess the safety of the treatment and use PET scans to evaluate the response to the treatment.

Patients will take ibrutinib by mouth every day for 28 days. This cycle will repeat every 28 days unless the disease progresses or side effects become too severe. Patients will also receive obinutuzumab through an IV on specific days during the first cycle and then on the first day of each following cycle. This treatment will continue for up to 6 cycles unless the disease progresses or side effects become too severe. After the 6 cycles, patients with stable disease will continue to receive obinutuzumab every 2 months for up to 12 doses.

After finishing the study treatment, patients will have follow-up visits monthly for 1 year, then every 3-6 months for 4 years, and once more a year later.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of slow-growing non-Hodgkin's lymphoma, such as follicular lymphoma or marginal zone lymphoma.
  • The cancer must be at stage II-IV and measurable by scans.
  • Cancer cells must have the CD20 marker.
  • Must have symptoms or conditions that require treatment, like large tumors or affected organs.
  • Be 18 years or older.
  • Be in good overall health, with a performance status score between 0 and 2.
  • Must be able to swallow pills.
  • Agree to follow the study requirements and provide informed consent.
  • Women must not be pregnant and must use effective birth control during and after treatment.
  • Men must also use effective birth control during and after treatment.
  • Have adequate blood cell counts and organ function as determined by specific tests.

Exclusion Criteria

  • Have had other cancers unless disease-free for 5 years, with some exceptions.
  • Have received prior treatment for lymphoma, including chemotherapy or immunotherapy.
  • Have large B cell transformation or central nervous system involvement.
  • Have bleeding disorders or require certain blood thinners.
  • Have active infections or certain viral infections like HIV or hepatitis.
  • Have received a live vaccine recently.
  • Be taking other investigational drugs or have had recent chemotherapy for other cancers.
  • Have uncontrolled autoimmune conditions or significant heart disease.
  • Have had recent major surgery or certain medical conditions that could affect safety.
  • Be pregnant or nursing, or have significant liver impairment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.