Clinical trial NCT02733380: Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma
Official title: The Efficacy and Safety of Chidamide Combined With VDDT Regimen（Vinorelbine，Liposomal Doxorubicin，Dexamethasone and Thalidomide） in Relapse and Refractory Patients With Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse Large B-Cell Lymphoma
Relapsed and refractory
Histone deacetylase inhibitor
Chidamide
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues
2. Failed with second-line therapy
3. Having at least one measurable lesions
4. Age between 18 to 75 years old
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
6. Neutrophils more than 1.5\*10\^9/L; Platelets more than 90\*10\^9/L Hemoglobin: more than 90g/L.
7. Life expectancy no less than 3 months
8. No receiving chemotherapy in 4 weeks before enrollment
9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Pregnant ，lactating and patients at reproductive age who refuse to practice contraception
2. QTc prolonging \>450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication.
3. Organ transplant recipients
4. Active bleeding
5. Thrombus，embolism，cerebral hemorrhage，cerebral infarction
6. Important organ operation in less than 6 weeks
7. Abnormal liver function（Note：total bilirubin \>1.5 times the upper limit of normal，AST or ALT \>2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine \>1.5 times the upper limit of normal），fluid and electrolyte disorders
8. Mental illness or unable to sign the informed consent
9. Drug addiction history or alcoholism which may interfere the experimental results.
10. Researchers determine unsuited to participate in this trial
11. Known allergy to any kind of study drugs

Primary outcomes:
measure: objective response rate
timeFrame: every 8 weeks until 1 year after last patient's enrollment
measure: adverse events
timeFrame: from the date of first cycle of treatment to 1 year after last patient's enrollment
measure: abnormal laboratory examinations
timeFrame: from the date of first enrollment to 1 year after last patient's enrollment
measure: incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
timeFrame: from the date of first cycle of treatment to 1 year after last patient's enrollment
Secondary outcomes:
measure: progression-free survival
timeFrame: from the day of treatment to the date of first documented progression，up to 1 year after last patient's enrollment
measure: duration of response
timeFrame: from the day of first documented response to first documented progression or death，up to 1 year after last patient's enrollment
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yanyan Liu, M.D. Ph.D
role: STUDY_DIRECTOR
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