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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

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).

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Chidamide Drug: Vinorelbine Drug: Liposomal Doxorubicin or mitoxantrone Drug: Dexamethasone Drug: Thalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733380


Contacts
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Contact: Yanyan Liu, M.D. Ph.D +8613818176375 yyliu@zzu.edu.cn
Contact: Jiuyang Zhang, Master +8615003810435 zhangjiuyang9103@163.com

Locations
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China, Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Recruiting
ZhengZhou, Henan, China, 450008
Contact: Yanyan Liu, M.D.    +8613838176375    yyliu@zzu.edu.cn   
Contact: Jiuyang Zhang, Master    +8615003810435    zhangjiuyang9103@163.com   
Principal Investigator: Yanyan Liu, M.D.         
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Study Director: Yanyan Liu, M.D. Ph.D Henan Cancer Hospital
Publications of Results:

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Responsible Party: Yanyan Liu, director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT02733380    
Other Study ID Numbers: HNSZLYYML-01
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: August 2018
Keywords provided by Yanyan Liu, Henan Cancer Hospital:
Diffuse Large B-Cell Lymphoma
Relapsed and refractory
Histone deacetylase inhibitor
Chidamide
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Thalidomide
Dexamethasone
Doxorubicin
Liposomal doxorubicin
Vinorelbine
Mitoxantrone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors