Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene

This phase Ib/II trial tests the safety, side effects, best dose and how well giving CX-5461 works for the treatment of patients with B-cell non-Hodgkin lymphoma. CX-5461 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CX-5461 may be safe, tolerable and/or effective in treating patients with B-cell non-Hodgkin lymphoma.

Trial Details

NCT ID
NCT07069699
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Lumbar Puncture
  • Pidnarulex
  • Positron Emission Tomography
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Fairway, Kansas, United States|39.02223,-94.6319
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Overland Park, Kansas, United States|38.98223,-94.67079

Key Eligibility Criteria

  • Patients must have one of the following subtypes of aggressive B-cell non-Hodgkin lymphomas: double-expressor lymphoma (DEL), high-grade B-cell lym…
  • Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of CX-5461 (Pidnarulex) in patients \< 18 years of …
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). ECOG 3 is allowed if directly related to lymphoma per treating …
  • Absolute neutrophil count ≥ 1,000/mcL

For full eligibility, visit ClinicalTrials.gov.

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