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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Decitabine

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Decitabine, ORR, TTP, OS, PFS

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oncology Department of The First Affilliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ORR

Objective Responder Rate

TTP

Time TO Progression

Secondary Outcome Measures

Overall Survival

PFS

Progression Free Survival

Full Information

NCT ID

NCT03579082

First Posted

December 14, 2017

Last Updated

September 12, 2018

Sponsor

Mingzhi Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03579082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Anticipated)

Study Completion Date

December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mingzhi Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

Keywords

Decitabine, ORR, TTP, OS, PFS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

5-Aza-2'-deoxycytidine

Intervention Description

Given ivgtt

Primary Outcome Measure Information:

Title

ORR

Description

Objective Responder Rate

Time Frame

up to 2 months

Title

TTP

Description

Time TO Progression

Time Frame

up to 2 months

Secondary Outcome Measure Information:

Title

Description

Overall Survival

Time Frame

up to 2 months

Title

PFS

Description

Progression Free Survival

Time Frame

up to 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

Mingzhi_zhang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi Zhang

Phone

13838565629

Mingzhi_zhang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang

Organizational Affiliation

The first affilliated hospital of zhengzhou university

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department of The First Affilliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

mingzhi_zhang@126.com

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Drc

Phone

13838565629

mingzhi_zhang@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34222013

Citation

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.

Results Reference

derived

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

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