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

NCT ID: NCT03579082

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-12-01

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.

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).

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

Given ivgtt

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decitabine

Given ivgtt

Intervention Type: DRUG

Other Intervention Names

5-Aza-2'-deoxycytidine

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

The director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mingzhi Zhang

Role: PRINCIPAL_INVESTIGATOR

The first affilliated hospital of zhengzhou university

Locations

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi Zhang, Pro,Dr

Role: CONTACT

Mingzhi_zhang@126.com

13838565629

Mingzhi Zhang

Role: CONTACT

Mingzhi_zhang@126.com

13838565629

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

mingzhi_zhang@126.com

13838565629

Mingzhi Zhang, Pro,Drc

Role: backup

mingzhi_zhang@126.com

13838565629

References

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.

Reference Type: DERIVED

PMID: 34222013 (View on PubMed)

Other Identifiers

hnslblzlzx20171211

Identifier Type: -

Identifier Source: org_study_id