Study on Using Ibrutinib After Initial Chemotherapy for Patients with Untreated Mantle Cell Lymphoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02242097

Provider View

This clinical trial is exploring whether the drug ibrutinib can be safely and effectively used as a follow-up treatment for patients with mantle cell lymphoma (MCL) who have already received initial chemotherapy. Ibrutinib works by blocking an enzyme that affects the growth and survival of cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to determine if ibrutinib can help maintain the health of patients with mantle cell lymphoma (MCL) after they have responded to initial chemotherapy. Ibrutinib is a medication that targets an enzyme involved in the growth of cancer cells. Researchers aim to assess how safe and effective ibrutinib is when used as a maintenance therapy for MCL.

Description

The study has several goals:

  • Primary Goal: To find out how long patients can live without their cancer getting worse after 3 years of treatment.

  • Secondary Goals: To check for any side effects, see if patients' responses to treatment improve from partial to complete, and determine the average overall survival after 4 years.

  • Additional Goals: To compare results from tests that detect small amounts of cancer over time and see how these relate to patient outcomes.

Patients will take ibrutinib by mouth once a day in 28-day cycles, continuing for up to 4 years unless the cancer progresses, side effects become unacceptable, or the patient chooses to stop. After finishing the treatment, patients will have follow-up visits to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mantle cell lymphoma (MCL).
  • Must have completed at least 4 cycles of specific chemotherapy regimens, such as R-CHOP or Bendamustine + Rituximab, with or without a stem cell transplant.
  • Must have shown a response to initial chemotherapy, either complete or partial, without any known progression.
  • May have received prior radiation therapy.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must meet specific blood count and organ function requirements.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a specified time after.
  • Must avoid consuming grapefruit or Seville oranges while on ibrutinib.
  • Must be able to understand and sign a written informed consent.

Exclusion Criteria

  • Cannot have taken ibrutinib for more than 7 days or any other similar drugs before.
  • Cannot be on other experimental treatments.
  • Cannot have received live vaccines within 4 weeks before starting the study.
  • Cannot have lymphoma that has spread to the brain.
  • Cannot have had major surgery within 4 weeks before starting the study.
  • Cannot have other active cancers unless they meet specific exceptions.
  • Cannot have had a stroke or brain bleeding within 6 months before starting the study.
  • Cannot require certain blood thinners or medications that interfere with ibrutinib.
  • Cannot have severe heart conditions or uncontrolled illnesses.
  • Cannot have HIV, active hepatitis, or certain viral infections.
  • Cannot be pregnant or breastfeeding.

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