DLBCL - Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
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
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
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | May 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: (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. Exclusion Criteria: 1. Primary and secondary central DLBCL; 2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease; 4) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family |
| Country | Name | City | State |
|---|---|---|---|
| China | Bing Xu | Xiamen | Fujian |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital of Xiamen University | Chinese Academy of Medical Sciences, Jiangsu Provincial People's Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete remission rate (CR) | CR is evaluated according to the Lugano criteria for lymphoma response. | Up to 36 months | |
| Secondary | Partial remission rate (PR) | PR is evaluated according to the Lugano criteria for lymphoma response. | Up to 36 months | |
| Secondary | Overall response rate (ORR) | Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria. | Up to 36 months | |
| Secondary | Progression Free Survival (PFS) | The Kaplan-Meier method will be used to estimate the rate of PFS. PFS was defined as the time from the date of treatment initiation until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Up to 36 months |