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
128 participants
INTERVENTIONAL
2019-07-17
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RCHOP
Cyclophosphamide
750mg/m2 day 1
Rituximab
375mg/m2 day 0
Doxorubicin
50mg/m2 day 1
Vincristine
1.4mg/m2, max 2mg day 1
Prednisone
60mg/m2, max 100mg day 1-5
RCHOPX
Cyclophosphamide
750mg/m2 day 1
Rituximab
375mg/m2 day 0
Doxorubicin
50mg/m2 day 1
Vincristine
1.4mg/m2, max 2mg day 1
Prednisone
60mg/m2, max 100mg day 1-5
Ibrutinib
420mg/day qd
Lenalidomide
25mg day1-10
chidamide
20mg day 1,4,8,11
decitabine
decitabine 10mg/m2 day-5 to day-1
Interventions
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Cyclophosphamide
750mg/m2 day 1
Rituximab
375mg/m2 day 0
Doxorubicin
50mg/m2 day 1
Vincristine
1.4mg/m2, max 2mg day 1
Prednisone
60mg/m2, max 100mg day 1-5
Ibrutinib
420mg/day qd
Lenalidomide
25mg day1-10
chidamide
20mg day 1,4,8,11
decitabine
decitabine 10mg/m2 day-5 to day-1
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Deputy director of hematology department
Locations
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Ruijin hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Pp X, MD, PhD
Role: primary
Other Identifiers
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Guidance-01
Identifier Type: -
Identifier Source: org_study_id