A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma

Study Overview
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Brief Summary
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To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.

Detailed Description
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This is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with R±DHAP in replase and refractory Diffuse Large B cell lymphoma.A total of 60 patients are planned to be enrolled into the study.Patients with diagnosis of replase and refractory Diffuse Large B cell lymphoma will be into two groups,and be treated with decitabine pluse R±DHAP or only R±DHAP,respectively.The primary end points are objective responder rate(ORR) and time to progression(TTP) and the secondary end points include overall survival(OS) and progression free survival(PFS).

Official Title
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A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age:14-65 years;ECOG rate≤2;expected survival≥3 months patients with Diffuse Large B cell lymphoma diagnoesd by histopathology detection; patients ever received RCHOP or CHOP chemotherapy but did not receive DHAP patients never received radiotherapy patients with no chemotherapy contraindications:hemoglobin ≥ 90g/L,absoluate neutrophil count ≥1.5x109/L,blood platelet ≥100x109/L,ALT and AST ≤ 2-fold upper normal limit,serum bilirubin ≤1.5-fold upper normal limit,serum creatinine ≤1.5-fold upper normal limit,serum albumin ≥ 30g/L,normal serofibrinogen; at least one measurable nidus; no other severe diseases conflict with this project,cardiopulmonary function is basically normal the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit; applicable for follow-up visit; no other antitumor adjoint therapy(including antitumor Chinese medicine,immunotherapy and biotherapy),but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable; understanding this study and assigning informed consent. Exclusion Criteria: rejecting providing blood preparation; allergic to drug in this study and with metabolic block; rejecting adopting reliable contraceptive method in pregnancy or lactation period; uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）； with severe infection; with primary or secondary central nervous system tumor invasion; with immunotherapy or radiotherapy contraindication; ever suffered with malignant tumor; having peripheral nervous system disorder or dysphrenia; with no legal capacity,medical or ethical reasons affecting research proceeding; participating other clinical trials simultaneously; adopting other anti-tumor medicine excluding this research; the researchers considering it inappropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Arm A<br>R±DHAP + decitabine: decitabine:10mg/d,ivgtt,d(-5)-(-1);R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. | Drug: Decitabine<br>* Given ivgtt<br>* Other names: 5-Aza-2'-deoxycytidine;|
| No Intervention: Arm B<br>R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Responder Rate | up to 2 months | 
| TTP | Time TO Progression | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | up to 2 months | 
| PFS | Progression Free Survival | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORR, Decitabine, TTP, OS, PFS