A Phase III Study of Ibrutinib with Rituximab in People with Untreated Marginal Zone Lymphoma

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Full Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study of Ibrutinib in Combination with Rituximab in Subjects with Treatment Naïve Marginal Zone Lymphoma

Purpose

The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma (a type of non-Hodgkin lymphoma) who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better. Patients will be randomly assigned to receive one treatment combination or the other.

Ibrutinib and rituximab are both used to treat lymphoma. Their use together in patients with marginal zone lymphoma without prior treatment is considered investigational. Ibrutinib is taken orally (by mouth) and rituximab is given intravenously (by vein) or subcutaneously (under the skin).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have marginal zone lymphoma that has not yet been treated with systemic therapy (chemotherapy). Prior treatment with antibiotics for H. pylori, C. psittaci, or B. burgdorferi or antiviral therapy for the hepatitis C virus is permitted.
  • Patients are eligible if they had surgery to remove the spleen or other local treatment and now need systemic therapy.
  • Evidence should exist that the patient requires systemic treatment, such as organ failure, bulky disease, systemic symptoms, or the need for a blood transfusion or support with blood growth factors.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ariela Noy at 212-639-7423.

Protocol

19-243

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators