An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety,Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 inPatients with Relapsed or Refractory Primary Central Nervous System Lymphoma
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This study is being done to test the orally administered study drug, CA-4948 in combination with ibrutinib in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in non-Hodgkin’s Lymphoma (NHL) and other hematological malignancies. When these signals are not working properly, they can trigger cancer growth. By blocking IRAK4, the study drug may stop or reduce these signals and help fight your cancer. Ibrutinib is a medication used to treat adults with certain kinds of leukemia and is commercially available. It has been approved by the United States Food and Drug Administration (FDA) for the treatment of various types of cancer. CA-4948 in combination with ibrutinib is considered “Investigational” treatment as this combination of study drugs is experimental and has not been approved as a marketed product (i.e., available to be prescribed or sold) by any regulatory authorities, such as the FDA. Ibrutinib is also not FDA approved to treat PCNSL
Are you Eligible? (Inclusion Criteria)
- Must be 18 years or older - Must be able to swallow and retain oral medications - Willing and able to provide written informed consent and comply with the requirements of the trial - Must have confirmed diagnosis of Primary Central Nervous System Lymphoma (PCNSL)