Neoplasms Clinical Trial
Official title:
A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation
The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP (rituximab/gemcitabine/dexamethasone/cisplatin)in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.
Status | Recruiting |
Enrollment | 63 |
Est. completion date | March 1, 2021 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Ages: 18-75 years old 2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy 3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT) 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2 5. Informed consent available 6. Life expectancy of more than 3 months; 7. Ultrasonic cardiogram showed left ventricle ejection fraction = 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention. 8. Bone marrow function: ANC = 1.5 × 109/L, PLT = 100 × 109/L, Hb = 80g/L; 9. Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value) 10. Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min Exclusion Criteria: 1. Prior history of treatment of HDAC inhibitor. 2. Plan of HSCT in the future 3. Significant pericardial effusion showed by chest CT scan 4. Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation 5. Syphilis or human immunodeficiency virus (HIV) infection 6. Pregnant or lactating women 7. History of organ transplantation 8. Serious active infections (including hepatitis) 9. Serious neurological or psychiatric history, including dementia or epilepsy. Termination criteria: 1. Withdrew consent 2. Researchers think it is necessary to terminate the study; 3. Disease progression or death; 4. Poor compliance 5. Subclinical or clinical cardiac toxicity; 6. Unable to continue treatment because of severe toxicity |
Country | Name | City | State |
---|---|---|---|
China | Kai Xue | Shanghai | Shanghai |
China | Kai Xue | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | overall response rate | 6 weeks | |
Secondary | CR | complete response | 6 weeks | |
Secondary | OS | overall survival | 3 years | |
Secondary | 3 year PFS | 3 year progression free survival | 3 years | |
Secondary | adverse event | adverse event related to treatment | throughout the treatment period,up to 6 months |
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