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Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02733380
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Yanyan Liu, Henan Cancer Hospital

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date April 1, 2020
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • objective response rate [ Time Frame: every 8 weeks until 1 year after last patient's enrollment ]
    the total proportion of patients with complete response(CR or CRu)and partial response(PR)
  • adverse events [ Time Frame: from the date of first cycle of treatment to 1 year after last patient's enrollment ]
    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
  • abnormal laboratory examinations [ Time Frame: from the date of first enrollment to 1 year after last patient's enrollment ]
    includes type, incidence, relationship with treatment and severity of abnormal laboratory examinations.
  • incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations [ Time Frame: from the date of first cycle of treatment to 1 year after last patient's enrollment ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • progression-free survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 1 year after last patient's enrollment ]
    from date of first day of treatment to the date of first documented
  • duration of response [ Time Frame: from the day of first documented response to first documented progression or death,up to 1 year after last patient's enrollment ]
    from the first day of documented response to disease progression or death.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE
  • Drug: Chidamide
    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
  • Drug: Vinorelbine
    20mg/m2, IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
  • Drug: Liposomal Doxorubicin or mitoxantrone
    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
  • Drug: Dexamethasone
    10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
  • Drug: Thalidomide
    100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks
Study Arms  ICMJE Experimental: Chidamide combined with VDDT regimen
Chidamide 30mg,Oral twice a week with an interval of no less than 3 days combined with regimen:VDDT(Vinorelbine,Liposomal doxorubicin or mitoxantrone ,Dexamethasone and Thalidomide):repeated every 14 days ,up to 12 cycles
Interventions:
  • Drug: Chidamide
  • Drug: Vinorelbine
  • Drug: Liposomal Doxorubicin or mitoxantrone
  • Drug: Dexamethasone
  • Drug: Thalidomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yanyan Liu, M.D. Ph.D +8613818176375 yyliu@zzu.edu.cn
Contact: Jiuyang Zhang, Master +8615003810435 zhangjiuyang9103@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733380
Other Study ID Numbers  ICMJE HNSZLYYML-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanyan Liu, Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yanyan Liu, M.D. Ph.D Henan Cancer Hospital
PRS Account Henan Cancer Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP