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

NCT03579082 | Unknown Phase 4 FDA Drug

• 1 other identifier: hnslblzlzx20171211
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Decitabine; ORR; TTP; OS; PFS

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Responder Rate

  up to 2 months

• TTP

  Time TO Progression

  up to 2 months

Secondary Outcomes (2)

• OS

  up to 2 months

• PFS

  up to 2 months

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

NO INTERVENTION

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.

Interventions

Decitabine DRUG

Given ivgtt

Also known as: 5-Aza-2'-deoxycytidine

Arm A

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34222013 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Mingzhi Zhang

  The first affilliated hospital of zhengzhou university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi Zhang, Pro,Dr

CONTACT

13838565629; Mingzhi_zhang@126.com

Mingzhi Zhang

CONTACT

13838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: July 6, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

CN (1)