Phase
Condition
Lymphoproliferative Disorders
Lymphoma
Vascular Diseases
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ages: 18-75 years old
Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated withstandard chemoimmunotherapy
Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2
Informed consent available
Life expectancy of more than 3 months;
Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed onsigns of myocardial ischemia, with no previous arrhythmia which need pharmacologicalintervention.
Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit ofnormal value)
Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min
Exclusion
Exclusion Criteria:
Prior history of treatment of HDAC inhibitor.
Plan of HSCT in the future
Significant pericardial effusion showed by chest CT scan
Prior history of other cancers except treated cervical or basal cell skin carcinoma,organ transplantation
Syphilis or human immunodeficiency virus (HIV) infection
Pregnant or lactating women
History of organ transplantation
Serious active infections (including hepatitis)
Serious neurological or psychiatric history, including dementia or epilepsy. Termination criteria:
Withdrew consent
Researchers think it is necessary to terminate the study;
Disease progression or death;
Poor compliance
Subclinical or clinical cardiac toxicity;
Unable to continue treatment because of severe toxicity
Study Design
Study Description
Connect with a study center
Kai Xue
Shanghai,
ChinaActive - Recruiting

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