Actively Recruiting
A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP for Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
J
Jiangsu Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and side effects of combining Azacitidine with R-CHOP chemotherapy in treating patients with newly diagnosed TP53-mutated Diffuse Large B-cell Lymphoma (DLBCL). This Phase 2, open-label study focuses on important outcomes like complete remission, overall survival, and progression-free survival. Participants will receive a specified dose of Azacitidine subcutaneously from day 1 to day 5, along with R-CHOP components including Rituximab, Cyclophosphamide, Epirubicin or Liposomal Adriamycin, Vincristine, and Prednisone administered on scheduled days. The study involves a single treatment arm using this combination, monitored over a period of up to 36 months. During the study, participants will undergo regular assessments to measure response rates such as complete and partial remission, overall response, and progression-free survival. Safety and side effects will be closely monitored throughout. The study aims to follow participants for up to three years to understand long-term outcomes and treatment effects.
CONDITIONS
Brief Title
AZA Combined With RCHOP in P53-mutated DLBCL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Newly diagnosed TP53-mutated Diffuse Large B-cell Lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Left ventricular ejection fraction (LVEF) greater than 45%
- HBV-positive carriers only if HBV-DNA test is negative prior to enrollment
- Liver function: serum bilirubin ≤ 2.0 times upper limit of normal (ULN), serum ALT and AST ≤ 2.5 times ULN
- Renal function: serum creatinine ≤ 2.0 times ULN unless due to lymphoma
- Life expectancy of at least 6 months
- Signed informed consent
You will not qualify if you...
- Primary or secondary central nervous system Diffuse Large B-cell Lymphoma
- HIV-positive or active hepatitis C virus infection
- Clinically significant secondary cardiovascular diseases
- Severe chronic obstructive pulmonary disease with hypoxemia
- Active bacterial, fungal, or viral infections not controlled by systemic therapy
- Other malignant tumors within the last 3 years or concurrent, except certain cured or early-stage cancers not requiring systemic therapy
- Known allergy or hypersensitivity to antibodies or proteins from the murine family
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive Azacitidine in combination with R-CHOP, a drug regimen given on specified days in cycles.
Repeated treatment cycles with visits for drug administration and monitoring
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
Z
Zhifeng Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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