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An open, single-arm study of azacytidine with R-CHOP (ARCHOP) for TP53 mutated de novo diffuse large B-cell lymphoma

An open, single-arm study of azacytidine with R-CHOP (ARCHOP) for TP53 mutated de novo diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072324
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse large B cell lymphoma

Interventions

TP53 mutated de novo diffuse large B cell lymphoma:ARCHOP

Sponsors

the First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Age between 18 to 70 years old (including 18 and 70); 2)Confirmed treatment-naïve TP53 mutated de novo diffuse large B cell lymphoma, Immunohistochemistry showed that TP53 was not expressed or exceeded 50%; 3)ECOG score 0-2; 4)cardiac ejection fraction of >45%; 5)HBV negative or HBV positive patient required to have HBV DNA<1.0×10^3 IU/ml before entering the group; 6)Adequate organ function ( serum bilirubin = 2x ULN, AST or ALT= 2.5 x ULN, and CRE= 2 x ULN unless due to lymphoma with documentation of normal function prior to onset of lymphoma; 7)Life expectancy no less than 6 months; 8)Able to give informed consent

Exclusion criteria

Exclusion criteria: 1)Symptomatic CNS lymphoma involvement; 2)Known HIV infection or HCV Active infection(HCV DNA positive); 3) Clinically symptomatic secondary cardiovascular diseases such as uncontrolled hypertension (resting diastolic blood pressure > 115 mmHg), uncontrolled arrhythmias, symptomatic angina, or NYHA CLASS III-IV congestive heart failure; 4)severe chronic obstructive pulmonary disease with hypoxemia; 5)Uncontrollable systemic infection(Bacteria, fungi and/or viruses); 6)Past or present co-existing malignancies (other than non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past three years); 7)Hypersensitivity or allergic reactions to murine antibodies or proteins

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;

Countries

China

Contacts

Public Contactbing xu

The First Affiliated Hospital of Xiamen University

xubingzhangjian@126.com+86 592 213 7255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026