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AZA Combined With RCHOP in P53-mutated DLBCL.
RECRUITINGPhase 2Sponsored by The First Affiliated Hospital of Xiamen University
Actively Recruiting
PhasePhase 2
SponsorThe First Affiliated Hospital of Xiamen University
Started2023-11-22
Est. completion2026-05-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06158399
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
Age: 18 Years – 70 YearsHealthy volunteers accepted
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
Conditions3
CancerDLBCL - Diffuse Large B Cell LymphomaTP53
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Actively Recruiting
PhasePhase 2
SponsorThe First Affiliated Hospital of Xiamen University
Started2023-11-22
Est. completion2026-05-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06158399