Study on the Safety of Anti-Cancer Drug CX-5461 (Pidnarulex) for Treating Lymphoma with MYC Gene Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07069699
This clinical trial is testing the safety and effectiveness of a new drug, CX-5461, for treating patients with certain types of B-cell non-Hodgkin lymphoma. The study aims to find the best dose and understand how well the drug works in stopping cancer growth.
Patient Parameters
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Program Overview
This study is exploring a new treatment, CX-5461, for patients with B-cell non-Hodgkin lymphoma, a type of cancer. The drug works by blocking enzymes that cancer cells need to grow. The trial will test the safety, side effects, and best dose of CX-5461, and see how well it works in treating this type of cancer.
Description
The study is divided into two phases. In Phase 1, researchers will determine the safest dose of CX-5461 and study its side effects. They will also look at how the drug affects gene expression in lymphoma cells. In Phase 2, the focus will be on how well the drug works in shrinking tumors.
Participants will receive CX-5461 through an IV on specific days of each treatment cycle, which repeats every 21 days. The study includes regular scans, blood tests, and tumor biopsies to monitor the effects of the treatment.
After finishing the treatment, participants will have follow-up visits to check their health and the long-term effects of the drug. These visits will occur 30 days after treatment, then every 3-4 months for the first two years, and every 6 months for the next three years.
Eligibility Criteria
Inclusion Criteria
- Must have a specific type of aggressive B-cell non-Hodgkin lymphoma, such as double-expressor lymphoma or Burkitt lymphoma.
- Must have tried at least two previous treatments for diffuse large B-cell lymphoma or one for Burkitt lymphoma without success.
- Must be 18 years or older.
- Must be in relatively good health, with a performance status score of 2 or better.
- Must have certain blood counts and organ function levels within specified limits.
- HIV-positive patients can participate if their viral load is undetectable.
- Patients with hepatitis B or C must have controlled or cured infections.
- Must not have any other health conditions that could interfere with the study.
- Women and men must agree to use effective birth control during the study and for six months after.
- Must be willing to provide blood and tumor samples for research.
- Must understand and agree to the study requirements by signing a consent form.
Exclusion Criteria
- Must have recovered from any significant side effects of previous cancer treatments.
- Cannot take certain medications that interact with CX-5461.
- Cannot have a heart condition that affects the heart's electrical activity.
- Cannot be participating in another clinical trial.
- Cannot have allergies to similar drugs.
- Cannot have any uncontrolled illnesses that would make the study unsafe.
- Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
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