Study on Ibrutinib and Rituximab for Treating Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01880567

Provider View

This clinical trial is exploring how well the combination of ibrutinib and rituximab works in treating patients with mantle cell lymphoma that has either returned after treatment or has not responded to previous treatments. It also includes older patients who have been newly diagnosed with this type of cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if the combination of two drugs, ibrutinib and rituximab, can effectively treat mantle cell lymphoma (MCL). Ibrutinib works by blocking certain enzymes that help cancer cells grow, while rituximab is a type of antibody that targets and helps destroy cancer cells. This study is for patients whose MCL has come back or hasn't responded to treatment, as well as for older patients who have just been diagnosed with MCL.

Description

The study has several goals:

  • Primary Goals:

    • To see how well ibrutinib and rituximab work together in patients with MCL that has returned or not responded to treatment.
    • To evaluate the safety and effectiveness of this combination in older patients (over 65) who have just been diagnosed with MCL.

  • Secondary Goals:

    • To further assess the safety of the drug combination.
    • To measure how long patients respond to the treatment, how long they live without the disease getting worse, and their overall survival.

  • Exploratory Goals:

    • To study how gene mutations and changes in proteins relate to treatment response.

Patients in the study will take ibrutinib daily and receive rituximab through an IV on specific days. The treatment cycles repeat every 28 days, and patients will continue treatment as long as it is effective and safe. After finishing the treatment, patients will have follow-up visits every few months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • For patients with relapsed/refractory MCL:

    • Must have a confirmed diagnosis of mantle cell lymphoma.
    • Must have received at least one prior treatment for MCL.
    • Must be able to understand and sign a consent form.
    • Must have a performance status that allows for daily activities.
    • Must meet specific blood count and organ function criteria.
    • Must be willing to receive blood transfusions if needed.

  • For newly diagnosed MCL patients:

    • Must be over 65 years old with a confirmed diagnosis of MCL.
    • Must not have received any prior treatment for MCL.
    • Must have a performance status that allows for daily activities.
    • Must meet specific blood count and organ function criteria.
    • Must be willing to receive blood transfusions if needed.
    • Must have no other serious medical conditions that would interfere with the study.

Exclusion Criteria

  • For patients with relapsed/refractory MCL:

    • Cannot have serious medical conditions that pose a risk.
    • Cannot be pregnant or breastfeeding.
    • Cannot have active infections like HIV or hepatitis.
    • Cannot have had a stroke or heart issues recently.
    • Cannot have significant heart or gastrointestinal issues.
    • Cannot have had recent chemotherapy or certain medications.

  • For newly diagnosed MCL patients:

    • Cannot have serious medical conditions that pose a risk.
    • Cannot have active infections like HIV or hepatitis.
    • Cannot have had a stroke or heart issues recently.
    • Cannot have significant heart or gastrointestinal issues.
    • Cannot have had recent major surgery or certain medications.
    • Cannot have certain aggressive forms of MCL or large tumors.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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