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A single arm, open label study for evaluation the effect and saft of Chidamide in the treatment of HBV positive diffuse large B cell lymphoma

A single arm, open label study for evaluation the effect and saft of Chidamide in the treatment of HBV positive diffuse large B cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017698
Enrollment
Unknown
Registered
2018-08-10
Start date
2018-08-08
Completion date
Unknown
Last updated
2018-08-20

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

Case series:maintenance of Chidamide

Sponsors

the First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with DLBCL confirmed by histopathology are chronic hepatitis B before treatment; 2. after systemic treatment, complete remission was achieved and the complete remission time was less than 1 years. 3. completed the expected chemotherapy, the blood routine had been restored; 4. the absolute value of neutrophils is more than 1.5 x 10^9/L, platelets are more than 90 x 10^9/L, hemoglobin is more than 90g/L; 5. hematopoietic stem cell transplantation can not be performed for various reasons; 6. Aged 18-75 years old male and female; 7. ECOG stamina score was 0-1; 8. weight: male 67 + 20 kg (47-87 kg), female 55 + 20 kg (35-75 kg); 9. the expected survival time was more than 3 months; 10. voluntarily signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. pregnant and lactating women and childbearing age who are unwilling to take contraceptive measures; 2. patients (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), cardiac block, myocardial infarction (MI), congestive heart failure (CHF), and coronary heart disease with symptomatic medication for QTc interval; 3. the B-mode ultrasound showed that the patients with terminal diastolic pericardial fluid dark area were more than 10mm. 4. patients receiving organ transplantation; 5. in the first 7 days of admission, patients who received symptomatic treatment for pre myelosuppression were accepted within the first 7 days. 6. HBV nucleic acid quantitation > 103 IU/mL; 7. patients with active bleeding; 8. patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other diseases or history. 9. patients with active infection or those who had continued fever during the first 14 days of admission; 10. the main organs were not full 6 weeks after surgery; 11. abnormal liver function (total bilirubin > 1.5 times of the upper limit of normal value, ALT/AST > 2.5 times of the upper limit of normal value or 5 times the upper limit of normal value of the patients with liver invasion) and abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value). 12. persons with mental disorders / unable to obtain informed consent; 13. patients taking drugs and long-term alcoholism, which affect the evaluation of test results; 14. the researchers decided that it was not suitable for the participants to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactOu bai

The First Hospital of Jilin University

Oubai16@163.com+86 13029046656

Outcome results

None listed

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