Status:
UNKNOWN
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Experimental
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
Detailed Description
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and...
Eligibility Criteria
Inclusion
- Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
- Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
- At least one measurable lesion;
- Age 18-75 years, male or female;
- ECOG performance status 0-1;
- Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
- Life expectancy no less than 3 months;
- Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
- Patients have signed the Informed Consent Form.
Exclusion
- Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- Patients with active hemorrhage.
- Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- Had major organ surgery within 6 weeks prior to enrollment.
- Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- Patients with mental disorders or those do not have the ability to consent.
- Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- Patients who have central nervous system involvements;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03410004
Start Date
January 25 2018
End Date
September 30 2020
Last Update
January 25 2018
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