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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579082
• Other study ID #: hnslblzlzx20171211
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: September 2018
• Source: Zhengzhou University
• Contact: Mingzhi Zhang, Pro,Dr
• Phone: 13838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Decitabine
Given ivgtt

Locations

Country	Name	City	State
China	Oncology Department of The First Affilliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Responder Rate	up to 2 months
Primary	TTP	Time TO Progression	up to 2 months
Secondary	OS	Overall Survival	up to 2 months
Secondary	PFS	Progression Free Survival	up to 2 months