Study on Ibrutinib for Patients with Newly Diagnosed or Recurrent Central Nervous System Lymphoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02315326

Provider View

This clinical trial is testing the effects of a drug called Ibrutinib, also known as Imbruvica™, in patients with newly diagnosed or recurrent central nervous system lymphoma. The study aims to see if Ibrutinib can be added to standard chemotherapy to improve treatment outcomes.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of Ibrutinib, a drug also known as Imbruvica™, in patients with central nervous system lymphoma. Researchers are investigating whether Ibrutinib can be combined with standard chemotherapy drugs (rituximab, methotrexate, vincristine, and procarbazine) to improve treatment results for patients with newly diagnosed or recurrent central nervous system lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Men and women aged 18 or older.
  • Diagnosed with primary central nervous system lymphoma (PCNSL) or systemic diffuse large B-cell lymphoma (DLBCL).
  • Must have recurrent or treatment-resistant PCNSL or secondary central nervous system lymphoma (SCNSL), or newly diagnosed PCNSL.
  • Must have received at least one prior treatment targeting the central nervous system.
  • Must show disease progression on brain imaging or have lymphoma cells in the cerebrospinal fluid.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have adequate bone marrow and organ function based on specific blood tests.
  • Women of childbearing potential must use effective birth control during treatment and for 30 days after.
  • Men must use effective contraception during treatment and for 3 months after.
  • Must have a negative pregnancy test if applicable.
  • Must be able to undergo MRI/CT scans and lumbar puncture.
  • Must have recovered from previous treatment side effects.
  • Must provide tissue samples for diagnosis confirmation.

Exclusion Criteria

  • Currently receiving treatment for cancer outside the central nervous system.
  • Using other cancer treatments or investigational drugs.
  • Recent chemotherapy or radiation therapy within specified timeframes.
  • Requires more than 8 mg of dexamethasone daily.
  • Has another active cancer requiring treatment.
  • Recent treatment with certain radio- or toxin-immunoconjugates.
  • Allergic to study drug components.
  • Using certain blood thinners or medications affecting liver enzymes.
  • Using systemic immunosuppressants or high-dose steroids.
  • Has significant heart problems or abnormal EKG results.
  • Has bleeding disorders or is HIV positive.
  • Has active hepatitis B or C infections.
  • Has uncontrolled infections or recent major surgery.
  • Unable to swallow capsules or has digestive issues.
  • Poorly controlled diabetes.
  • Has a life-threatening illness or condition affecting safety.
  • Pregnant or nursing women.
  • Has had an allogenic stem cell transplant.
  • Unable to participate in study procedures or understand the study purpose.
  • Allergic to methotrexate (for certain study arms).
  • Has severe nerve damage (for certain study arms).

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