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

September 12, 2018 updated by: Mingzhi Zhang
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Oncology Department of The First Affilliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mingzhi Zhang

Investigators

  • Principal Investigator: Mingzhi Zhang, The first affilliated hospital of zhengzhou university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hnslblzlzx20171211

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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