Chidamide With R-CHOP Regimen for DLBCL Patients

Study Overview
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Brief Summary
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It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results. abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone. PR: partial remission; MRD:minimal residual disease;

Official Title
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Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Chidamide + R-CHOP regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results; Age between 18 to 75 years old; World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; Life expectancy no less than 6 months The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; IPI mark>1. Exclusion Criteria: History of autologous stem cell transplantation; History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; Lymphoma originated in the central nervous system; Left ventricular ejection fraction ≦50％ Abnormal lab results in enrollment: Neutrophil count: <1.5*109/L； Platelet count <75*109/L； AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level; serum creatinine >1.5 times the upper limit of normal level; Other uncontrolled medical conditions which the investigators think might influence the results of the trial; Patients with mental illnesses or other diseases that might not comply with the trial plan; Women during pregnancy or lactation; HIV positive patients; HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days； abbreviation： CTX： cyclophosphamide；EPI：etoposide；VCR： vincristine；Pred：prednisone； R-CHOP：the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone. | Drug: Chidamide + R-CHOP regimen<br>* Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days;<br>* Other names: HBI-8000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | complete remission rate after treated by Chidamide+ R-CHOP regimen | every 3 months until 30 months after the last patient's enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment | 
| overall survival | from the date of inclusion to date of death, irrespective of cause | 30 months after the last patient's enrollment | 
| adverse events | 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 | from the date of first cycle of treatment to 30 months after last patient's enrollment |