Study on CA-4948 for Patients with Relapsed or Hard-to-Treat Primary Central Nervous System Lymphoma

Sponsor: Curis, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03328078

Provider View

This clinical trial is testing the safety and effectiveness of a new oral medication, emavusertib (CA-4948), alone and in combination with another drug, ibrutinib, for adults with primary central nervous system lymphoma (PCNSL) that has returned or is difficult to treat.

Patient Parameters

Program Overview

This study is being conducted at multiple centers to evaluate a new oral medication called emavusertib (CA-4948) for adults with relapsed or refractory primary central nervous system lymphoma (PCNSL). The trial is divided into two parts. In the first part, the safety and tolerability of emavusertib were tested alone and in combination with ibrutinib, a medication taken once daily. The second part focuses on assessing the safety and effectiveness of the combination treatment specifically for patients with PCNSL.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Expected to live at least 3 more months.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Confirmed diagnosis of primary central nervous system lymphoma (PCNSL).
  • For patients with brain lesions, clear evidence of disease progression on recent imaging.
  • For patients with disease in the fluid around the brain and spinal cord, confirmation of lymphoma cells in the fluid or consistent imaging findings.

Exclusion Criteria

  • Patients with only eye involvement without brain or fluid involvement, or with T-cell lymphoma, or lymphoma that has spread to the brain from other parts of the body.
  • History of other cancers unless disease-free for 3 years, except for certain skin or cervical cancers.
  • Active cancer other than PCNSL needing treatment.
  • History of severe muscle breakdown (rhabdomyolysis) without full recovery.
  • Recent radiation therapy to the brain.
  • Recent use of investigational drugs or treatments, or recent stem cell transplant with ongoing immune suppression.
  • Recent systemic cancer treatments, except for ibrutinib, which can continue.
  • Allergic reactions to emavusertib or ibrutinib.

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