A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• (1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.
Locations
Other Locations
China
Bing Xu
RECRUITING
Xiamen
Contact Information
Primary
Bing Xu
xubingzhangjian@126.com
+8618750918842
Backup
Zhifeng Li
lzf_xm@163.com
+8613606901162
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 52
Treatments
Experimental: ARCHOP
Azacitidine in combination with R-CHOP
Related Therapeutic Areas
Sponsors
Collaborators: Shanxi Province Cancer Hospital, Chinese Academy of Medical Sciences, Jiangsu Provincial People's Hospital, Sun Yat-sen University
Leads: The First Affiliated Hospital of Xiamen University