Patient study inclusion criteria
tumor, transplantation failure, DLBCL, Relapsed DLBCL, 14–70
DISEASE PROGRESSION, DISEASE, TUMOR
This was an investigator‐initiated, prospective, randomized, controlled, open‐label clinical trial of R/R‐DLBCL patients registered at Patients were recruited for the study according to the following inclusion criteria: (1) age 14–70 years; (2) histologically confirmed DLBCL; (3) previous cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or rituximab plus CHOP (RCHOP) or failure of multiline treatments but not chemotherapy with the rituximab plus DHAP (RDHAP) regimen; (4) estimated survival time >3 months; (5) cases deemed unsuitable for transplantation, for reasons including disease progression, age, comorbidities, poor response to previous treatment, previous transplantation failure, and other conditions; (6) no chemotherapy contraindications; (7) at least one measurable lesion; (8) no uncontrolled medical disease. Relapsed DLBCL:complete response (CR) to initial chemotherapy was achieved and relapsed after 6 months. Refractory DLBCL: (1) tumor shrinkage <50% or disease progression after four cycles of standardized chemotherapy, (2) CR to initial chemotherapy was achieved and relapsed within 6 months, and (3) relapse after transplantation (refractory DLBCL can be diagnosed if one of these parameters is met).Between August 2018 and December 2021, 56 patients (35 in the decitabine‐RDHAP group and 21 in the RDHAP group) were evaluated to assess treatment efficacy. The study was approved by the Human Ethics Committee of the First Affiliated Hospital of Zhengzhou University and was conducted in accordance with the principles outlined in the Declaration of Helsinki. All the patients or their family members signed an informed consent form.