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NCT04661943CompletedPhase 2

Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma

Source: ClinicalTrials.gov · Last updated 24 Mar 2026

Brief summary (registry, in English)

A phase II,single arm,open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus(HBV)Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (actual)
First submitted
4 Dec 2020
Start date
1 Jun 2017
Primary completion date
31 Jul 2024
Lead sponsor
Ou Bai, MD/PHD
NCT number
NCT04661943

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 30
  • From 1 Jun 2017 to the primary completion date, 31 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with previous or planned organ transplantation
  • Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment
  • Patients with active infection or persistent fever within 14 days before enrollment
  • less than 6 weeks after major organ surgery
  • Patients with drug abuse and long-term alcohol abuse that affect evaluation

Other illness

  • HBV nucleic acid quantitation \> 103 IU / ml
  • Patients with active bleeding
  • Patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other this kind of diseases or medical history
  • Mental disorders/Those who cannot obtain informed consent

Lab values

  • Patients with prolonged QTc interval (male \> 450ms, female \> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and coronary heart disease with symptoms requiring drug treatment
  • Abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; ALT / AST \> 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST \> 5 times of upper limit of normal value for patients with liver metastasis \], abnormal renal function (serum creatinine \> 1.5 times of upper limit of normal value)

Age

  • Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures

Other

  • B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period
  • The investigator determined not suitable to participate in this study

Who the study is looking for

  • histopathology confirmed DLBCL,with chronic hepatitis B before treatment
  • After systemic treatment, complete response has been achieved and complete response lasted within 1year before enrollment
  • The expected chemotherapy was completed and the laboratory indexes returned to normal
  • The absolute value of neutrophil ≥ 1.5 × 10 9 / L, platelet count≥ 90 × 10 9 / L, hemoglobin level≥ 90 g / L
  • Patients who cannot undergo hematopoietic stem cell transplantation for various reasons
  • 18-75 years old, both male and female
  • ECOG PS 0-1
  • Body weight: male 67 ± 20 kg (47-87 kg), female 55 ± 20 kg (35-75 kg)
  • expected survival time ≥3 months
  • Voluntary written informed consent prior to trail screening

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Bethune Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.