Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma
NCT ID: NCT02733380
Last Updated: 2020-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2016-05-31
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Vinorelbine
20mg/m2， IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
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
Dexamethasone
10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
Thalidomide
100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks
Interventions
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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
Vinorelbine
20mg/m2， IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
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
Dexamethasone
10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
Thalidomide
100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Yanyan Liu
director
Principal Investigators
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Yanyan Liu, M.D. Ph.D
Role: STUDY_DIRECTOR
Henan Cancer Hospital
Locations
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Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wynder EL. Listen to nature. The challenge of lifestyle medicine. Soz Praventivmed. 1991;36(3):137-46. doi: 10.1007/BF01352692.
Witt O, Deubzer HE, Milde T, Oehme I. HDAC family: What are the cancer relevant targets? Cancer Lett. 2009 May 8;277(1):8-21. doi: 10.1016/j.canlet.2008.08.016. Epub 2008 Sep 27.
Khan AN, Tomasi TB. Histone deacetylase regulation of immune gene expression in tumor cells. Immunol Res. 2008;40(2):164-78. doi: 10.1007/s12026-007-0085-0.
Pasqualucci L, Dominguez-Sola D, Chiarenza A, Fabbri G, Grunn A, Trifonov V, Kasper LH, Lerach S, Tang H, Ma J, Rossi D, Chadburn A, Murty VV, Mullighan CG, Gaidano G, Rabadan R, Brindle PK, Dalla-Favera R. Inactivating mutations of acetyltransferase genes in B-cell lymphoma. Nature. 2011 Mar 10;471(7337):189-95. doi: 10.1038/nature09730.
Morin RD, Mendez-Lago M, Mungall AJ, Goya R, Mungall KL, Corbett RD, Johnson NA, Severson TM, Chiu R, Field M, Jackman S, Krzywinski M, Scott DW, Trinh DL, Tamura-Wells J, Li S, Firme MR, Rogic S, Griffith M, Chan S, Yakovenko O, Meyer IM, Zhao EY, Smailus D, Moksa M, Chittaranjan S, Rimsza L, Brooks-Wilson A, Spinelli JJ, Ben-Neriah S, Meissner B, Woolcock B, Boyle M, McDonald H, Tam A, Zhao Y, Delaney A, Zeng T, Tse K, Butterfield Y, Birol I, Holt R, Schein J, Horsman DE, Moore R, Jones SJ, Connors JM, Hirst M, Gascoyne RD, Marra MA. Frequent mutation of histone-modifying genes in non-Hodgkin lymphoma. Nature. 2011 Jul 27;476(7360):298-303. doi: 10.1038/nature10351.
Mondello P, Younes A. Emerging drugs for diffuse large B-cell lymphoma. Expert Rev Anticancer Ther. 2015 Apr;15(4):439-51. doi: 10.1586/14737140.2015.1009042. Epub 2015 Feb 5.
Dong M, Ning ZQ, Xing PY, Xu JL, Cao HX, Dou GF, Meng ZY, Shi YK, Lu XP, Feng FY. Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas. Cancer Chemother Pharmacol. 2012 Jun;69(6):1413-22. doi: 10.1007/s00280-012-1847-5. Epub 2012 Feb 24.
Ning ZQ, Li ZB, Newman MJ, Shan S, Wang XH, Pan DS, Zhang J, Dong M, Du X, Lu XP. Chidamide (CS055/HBI-8000): a new histone deacetylase inhibitor of the benzamide class with antitumor activity and the ability to enhance immune cell-mediated tumor cell cytotoxicity. Cancer Chemother Pharmacol. 2012 Apr;69(4):901-9. doi: 10.1007/s00280-011-1766-x. Epub 2011 Nov 12.
Gong K, Xie J, Yi H, Li W. CS055 (Chidamide/HBI-8000), a novel histone deacetylase inhibitor, induces G1 arrest, ROS-dependent apoptosis and differentiation in human leukaemia cells. Biochem J. 2012 May 1;443(3):735-46. doi: 10.1042/BJ20111685.
Zhou Y, Pan DS, Shan S, Zhu JZ, Zhang K, Yue XP, Nie LP, Wan J, Lu XP, Zhang W, Ning ZQ. Non-toxic dose chidamide synergistically enhances platinum-induced DNA damage responses and apoptosis in Non-Small-Cell lung cancer cells. Biomed Pharmacother. 2014 May;68(4):483-91. doi: 10.1016/j.biopha.2014.03.011. Epub 2014 Mar 18.
Frys S, Simons Z, Hu Q, Barth MJ, Gu JJ, Mavis C, Skitzki J, Song L, Czuczman MS, Hernandez-Ilizaliturri FJ. Entinostat, a novel histone deacetylase inhibitor is active in B-cell lymphoma and enhances the anti-tumour activity of rituximab and chemotherapy agents. Br J Haematol. 2015 May;169(4):506-19. doi: 10.1111/bjh.13318. Epub 2015 Feb 23.
Shimizu R, Kikuchi J, Wada T, Ozawa K, Kano Y, Furukawa Y. HDAC inhibitors augment cytotoxic activity of rituximab by upregulating CD20 expression on lymphoma cells. Leukemia. 2010 Oct;24(10):1760-8. doi: 10.1038/leu.2010.157. Epub 2010 Aug 5.
Other Identifiers
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HNSZLYYML-01
Identifier Type: -
Identifier Source: org_study_id
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