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

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: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: Decitabine

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

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Oncology Department of The First Affilliated Hospital of Zhengzhou University
      • Contact: Mingzhi Zhang, Pro,Drc; Phone Number: 13838565629; Email: mingzhi_zhang@126.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Hu J, Wang X, Chen F, Ding M, Dong M, Yang W, Yin M, Wu J, Zhang L, Fu X, Sun Z, Li L, Wang X, Li X, Guo S, Zhang D, Lu X, Leng Q, Zhang M, Zhu L, Zhang X, Chen Q. Combination of Decitabine and a Modified Regimen of Cisplatin, Cytarabine and Dexamethasone: A Potential Salvage Regimen for Relapsed or Refractory Diffuse Large B-Cell Lymphoma After Second-Line Treatment Failure. Front Oncol. 2021 Jun 18;11:687374. doi: 10.3389/fonc.2021.687374. eCollection 2021.

Study record dates

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: TTP; Decitabine; ORR; PFS; OS
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• 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