Actively Recruiting
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
50
Participants Needed
4
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have double-expressor lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, or Burkitt lymphoma
- Patients must have received at least two prior treatments for diffuse large B-cell lymphoma or one prior treatment for Burkitt lymphoma
- Disease must be refractory to or lack standard curative or palliative treatment options
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or better (Karnofsky 60% or higher); ECOG 3 allowed if due to lymphoma
- Absolute neutrophil count at least 1,000/mcL
- Platelet count at least 50,000/mcL
- Total bilirubin at or below 1.5 times institutional upper limit of normal (ULN), or up to 3 times ULN if Gilbert's syndrome with normal direct bilirubin
- AST/ALT levels at or below 3 times institutional ULN
- Glomerular filtration rate at least 60 mL/min
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B virus must have undetectable viral load on suppressive therapy if needed
- Patients with hepatitis C virus must be treated and cured or have undetectable viral load if currently on treatment
- Patients with prior or concurrent malignancy that does not interfere with safety or efficacy assessment
- Patients with cardiac disease history should be New York Heart Association class II or better
- Patients with cytopenia from bone marrow involvement or post CAR T-cell therapy if deemed safe
- No clinical evidence of central nervous system lymphoma
- Women of childbearing potential and men must agree to use contraception 14 days prior to and during study and for 6 months after last dose
- Willingness to provide blood and biopsy samples for research
- Ability to understand and sign informed consent
You will not qualify if you...
- Patients must have recovered from significant adverse events of prior cancer immunotherapy to grade 1 or less (except alopecia or lymphopenia)
- Use of strong CYP3A4 inhibitors or inducers that affect CX-5461 activity
- Baseline corrected QT interval greater than 480 milliseconds
- Receiving other investigational agents
- History of allergic reactions to compounds similar to CX-5461
- Uncontrolled illness or conditions that make participation hazardous
- Pregnant or breastfeeding women
- Women who are breastfeeding must discontinue during and for 6 months after treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
4
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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