Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma (NCT04661943) | Clinical Trial Compass
CompletedPhase 2
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
China30 participantsStarted 2017-06-01
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
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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 activ…