Status:
RECRUITING
AZA Combined With RCHOP in P53-mutated DLBCL.
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
Jiangsu Provincial People's Hospital
Sun Yat-sen University
Conditions:
DLBCL - Diffuse Large B Cell Lymphoma
TP53
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Detailed Description
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Azacitidine in combina...
Eligibility Criteria
Inclusion
- (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
- Primary and secondary central DLBCL;
- 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
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06158399
Start Date
November 22 2023
End Date
May 31 2026
Last Update
February 19 2025
Active Locations (1)
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1
Bing Xu
Xiamen, Fujian, China, 361000