🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-05-13)

Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma

🟢 Recruiting Phase 1 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Protocol Summary

This phase I trial tests the safety, side effects, and best dose of nivolumab in combination with ASTX727 in treating B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ASTX727 consists of the combination of decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving nivolumab in combination with ASTX727 may shrink and stabilize cancer.

Primary Research Facility: University of Alabama at Birmingham Cancer Center (Birmingham, Alabama)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Recurrent B-Cell Non-Hodgkin Lymphoma?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 9 Registered Participating Sites

📍 Primary Site Map

Site: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama

📍 All Participating Trial Locations (9 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of Alabama at Birmingham Cancer Center — Birmingham, Alabama

2. City of Hope Comprehensive Cancer Center — Duarte, California • Contact: (800) 826-4673

3. University of California Davis Comprehensive Cancer Center — Sacramento, California • Contact: (916) 734-3089

4. Yale University — New Haven, Connecticut • Contact: (203) 785-5702

5. University of Chicago Comprehensive Cancer Center — Chicago, Illinois • Contact: (773) 702-8222

6. UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois • Contact: (773) 702-8222

7. University of Chicago Medicine-Orland Park — Orland Park, Illinois • Contact: (773) 702-8222

8. NYU Langone Hospital - Long Island — Mineola, New York • Contact: (212) 263-4432

9. Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05272384 • Last Synced: 2026-05-13

View on ClinicalTrials.gov ↗