A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma
- Registration Number
- NCT03579082
- Lead Sponsor
- Mingzhi Zhang
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Decitabine 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.
- Primary Outcome Measures
Name Time Method TTP up to 2 months Time TO Progression
ORR up to 2 months Objective Responder Rate
- Secondary Outcome Measures
Name Time Method PFS up to 2 months Progression Free Survival
OS up to 2 months Overall Survival
Trial Locations
- Locations (1)
Oncology Department of The First Affilliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China