This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).
There are one third of diffuse large B-cell Lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. Vinorelbine，liposomal doxorubicin，mitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with Second-line treatments in our center. This regimen is well tolerated but the effect needs to be improved. Chidamide，a histone deacetylase inhibitor has been approved for the treatment of refractory T-cell lymphoma in China. The goal is to assess the efficacy and safety of chidamide combined with VDDT（vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide） in relapse and refractory patients with diffuse large B-cell Lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
30mg , Oral twice a week(with an interval of no less than 3 days,;e.g. Monday and Thursday，Tuesday and Friday) until disease progression or unacceptable toxicity develops
20mg/m2， IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
20mg/m2, IV on day 1 of each 14 day cycle（Note：for patients who can not afford the liposomal doxorubicin，may be replaced into mitoxantrone 8mg/m2, IV on day1 of each 14 day cycle） until disease progression or unacceptable toxicity develops, up to 12 cycles
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
RECRUITINGobjective response rate
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
Time frame: every 8 weeks until 1 year after last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of first cycle of treatment to 1 year after last patient's enrollment
abnormal laboratory examinations
includes type, incidence, relationship with treatment and severity of abnormal laboratory examinations.
Time frame: from the date of first enrollment to 1 year after last patient's enrollment
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations
Time frame: from the date of first cycle of treatment to 1 year after last patient's enrollment
progression-free survival
from date of first day of treatment to the date of first documented
Time frame: from the day of treatment to the date of first documented progression，up to 1 year after last patient's enrollment
duration of response
from the first day of documented response to disease progression or death.
Time frame: from the day of first documented response to first documented progression or death，up to 1 year after last patient's enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks