Biomarker Guided Treatment in DLBCL

Study Overview
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Brief Summary
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This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma

Official Title
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A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Rituximab
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone
* Drug: Ibrutinib
* Drug: Lenalidomide
* Drug: chidamide
* Drug: decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive ECOG 0,1,2 Life expectancy>6 months Informed consented IPI>1 Exclusion Criteria: Chemotherapy before 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RCHOP<br> | Drug: Cyclophosphamide<br>* 750mg/m2 day 1<br>Drug: Rituximab<br>* 375mg/m2 day 0<br>Drug: Doxorubicin<br>* 50mg/m2 day 1<br>Drug: Vincristine<br>* 1.4mg/m2, max 2mg day 1<br>Drug: Prednisone<br>* 60mg/m2, max 100mg day 1-5<br>|
| Experimental: RCHOPX<br> | Drug: Cyclophosphamide<br>* 750mg/m2 day 1<br>Drug: Rituximab<br>* 375mg/m2 day 0<br>Drug: Doxorubicin<br>* 50mg/m2 day 1<br>Drug: Vincristine<br>* 1.4mg/m2, max 2mg day 1<br>Drug: Prednisone<br>* 60mg/m2, max 100mg day 1-5<br>Drug: Ibrutinib<br>* 420mg/day qd<br>Drug: Lenalidomide<br>* 25mg day1-10<br>Drug: chidamide<br>* 20mg day 1,4,8,11<br>Drug: decitabine<br>* decitabine 10mg/m2 day-5 to day-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  | 21 days after 6 cycles of treatment (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 year | 
| overall survival |  | 2 year | 
| overall response rate |  | 21 days after 6 cycles of treatment (each cycle is 21 days) | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |  | Up to 30 days after completion of study treatment |