New maintenance drug shows promise for lymphoma patients with hepatitis b
NCT ID NCT04661943
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug chidamide as a maintenance treatment for 30 people with a type of lymphoma (DLBCL) who also have hepatitis B. All participants had finished chemotherapy and their cancer was in complete remission. The goal was to see if chidamide could help keep the cancer from coming back. The study was completed and looked at how long patients lived without their cancer returning.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Jul 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures * 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 * B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period * Patients with previous or planned organ transplantation * Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment * 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 * Patients with active infection or persistent fever within 14 days before enrollment * less than 6 weeks after major organ surgery * 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) * Mental disorders/Those who cannot obtain informed consent * Patients with drug abuse and long-term alcohol abuse that affect evaluation * The investigator determined not suitable to participate in this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
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