A new phase 2 clinical trial is recruiting patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) to investigate the effectiveness of combined treatment with decitabine and an immune checkpoint inhibitor (antiPD-1).
Participants will follow a 3-week cycle where they will receive 10 mg of decitabine per day for the first 5 days, followed by 200 mg of antiPD-1 therapy on day 8. Treatment will continue for 2 years or until the disease progresses, unacceptable toxicity occurs, or the participant withdraws from the study.
Read more about DLBCL experimental therapies
The study’s primary outcome measure will be the objective response rate during the first year. Other outcome measures will include the percentage of participants who achieve at least a minimal response during treatment, the length of time between treatment and disease progression or death (progression-free survival), and the overall survival time.
In addition, the time between treatment initiation and the first report of disease remission, observed through a partial response or higher, will be recorded. The study will also assess the duration of remission, recorded from the first report of disease remission until disease progression.
The study aims to enroll 20 participants between the ages of 14 and 80 years at a single clinical site at the Chinese PLA General Hospital in Beijing. Patients must have pathologically confirmed relapsed/remitting DLBCL with extranodal involvement (especially the central nervous system).
Participants must also have an expected survival time of at least 3 months, no active infection or severe mental illness, an Eastern Cooperative Oncology Group score between 0 and 2, aspartate aminotransferase and alanine aminotransferase levels ≤3.0 upper limit of normal (ULN), and total bilirubin levels ≤1.0 ULN.
Recruitment has begun for the trial, and the estimated primary completion date is March 1, 2025. The final completion date is estimated to be March 1, 2026.
Reference
Decitabine and anti-PD-1 in R/R DLBCL. ClinicalTrials.gov. April 18, 2023. Updated April 20, 2023. Accessed April 27, 2023.
