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
49 participants
INTERVENTIONAL
2016-04-30
2019-04-30
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 plus R-CHOP
Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Chidamide
Interventions
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Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Chidamide
Eligibility Criteria
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Inclusion Criteria
* Age 61-75 years
* ECOG 0,1,2
* Life expectancy\>6 months
* Informed consented
* IPI\>1
Exclusion Criteria
* Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* LVEF≤50%
* Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection
* If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
61 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Locations
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weili Zhao, MD,PhD
Role: primary
Pengpeng Xu, MD
Role: backup
References
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Zhang MC, Fang Y, Wang L, Cheng S, Fu D, He Y, Zhao Y, Wang CF, Jiang XF, Song Q, Xu PP, Zhao WL. Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma. Clin Epigenetics. 2020 Oct 23;12(1):160. doi: 10.1186/s13148-020-00948-9.
Other Identifiers
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CR-CHOP
Identifier Type: -
Identifier Source: org_study_id