Status:
UNKNOWN
Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Lead Sponsor:
Fudan University
Conditions:
Chidamide
Lymphoma, B-Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 Dif...
Detailed Description
The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is ch...
Eligibility Criteria
Inclusion
- Ages: 18-75 years old
- Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard 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 on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- 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 of normal value)
- Renal function: Cr\<1.5 × UNL and creatinine clearance \> 50ml/min
Exclusion
- 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
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03373019
Start Date
December 21 2017
End Date
March 1 2021
Last Update
December 14 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Kai Xue
Shanghai, Shanghai Municipality, China, 200032
2
Kai Xue
Shanghai, China