Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
NCT ID: NCT04661943
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-11-30
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Chidamide Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)
Tucidinostat
Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)
Interventions
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Tucidinostat
Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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oubai
OTHER
Responsible Party
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oubai
M.D.
Locations
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Ou BAI, doctor
Role: primary
Other Identifiers
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CDB0369
Identifier Type: -
Identifier Source: org_study_id