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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03579082
Recruitment Status : Unknown
Verified September 2018 by Mingzhi Zhang, Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : July 6, 2018
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Decitabine Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Arm A

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
Given ivgtt
Other Name: 5-Aza-2'-deoxycytidine

No Intervention: Arm B
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 :
  1. ORR [ Time Frame: up to 2 months ]
    Objective Responder Rate

  2. TTP [ Time Frame: up to 2 months ]
    Time TO Progression

Secondary Outcome Measures :
  1. OS [ Time Frame: up to 2 months ]
    Overall Survival

  2. PFS [ Time Frame: up to 2 months ]
    Progression Free Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03579082

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Contact: Mingzhi Zhang, Pro,Dr 13838565629
Contact: Mingzhi Zhang 13838565629

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China, Henan
Oncology Department of The First Affilliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629   
Contact: Mingzhi Zhang, Pro,Drc    13838565629   
Sponsors and Collaborators
Mingzhi Zhang
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Principal Investigator: Mingzhi Zhang The first affilliated hospital of zhengzhou university
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Responsible Party: Mingzhi Zhang, The director of oncology department of the first affiliated hospital, Zhengzhou University Identifier: NCT03579082    
Other Study ID Numbers: hnslblzlzx20171211
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mingzhi Zhang, Zhengzhou University:
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors