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Decitabine and Anti-PD-1 in R/R DLBCL

Primary Purpose

Diffuse Large B Cell Lymphoma, Relapse/Recurrence, Extranodal Extension

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low-Dose Decitabine plus anti-PD-1
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 14-80 years old, male or female; Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement; Expected survival of more than 3 months; AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN; Inactive infection and severe mental illness ECOG score 0~2 According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction >50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion The serum pregnancy test of female subjects must be negative Signed informed consent Exclusion Criteria: Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors; Severe uncontrolled medical disease or active infection (including HIV+); Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding; Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies; Pregnant or nursing women; Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases); The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.) The situation that the researcher judged was not suitable for inclusion

Sites / Locations

  • ChinaPLAGHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8

Outcomes

Primary Outcome Measures

Objective Response Rate
ORR

Secondary Outcome Measures

Clinical Benefit Rate
The total percentage of subjects who achieved minimal response (MR) or above after treatment
Progression Free Survival
The time interval between first treatment and first recorded progress disease, or death from any cause, the deadline is the date of the last examination
Duration of Remission
The time interval from first recording to disease remission (PR and above criteria) to first recording to PD. For responding subjects with no documented disease progression, the deadline is the date of the last examination
Time to Response
The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)
Overall Survival
The time interval between when the subject first received treatment and when death from any cause was recorded. For subjects whose death is not recorded, the deadline is the most recent point in time at which the subject is still alive

Full Information

First Posted
April 5, 2023
Last Updated
May 8, 2023
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05816746
Brief Title
Decitabine and Anti-PD-1 in R/R DLBCL
Official Title
Low-Dose Decitabine Plus Anti-PD-1 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma With Extranodal (Esp. Central Nervous System) Involvement: A PhaseⅡClinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.
Detailed Description
To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma, Relapse/Recurrence, Extranodal Extension, Central Nervous System Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8
Intervention Type
Drug
Intervention Name(s)
Low-Dose Decitabine plus anti-PD-1
Other Intervention Name(s)
DP
Intervention Description
Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
ORR
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Clinical Benefit Rate
Description
The total percentage of subjects who achieved minimal response (MR) or above after treatment
Time Frame
1-year
Title
Progression Free Survival
Description
The time interval between first treatment and first recorded progress disease, or death from any cause, the deadline is the date of the last examination
Time Frame
1-year
Title
Duration of Remission
Description
The time interval from first recording to disease remission (PR and above criteria) to first recording to PD. For responding subjects with no documented disease progression, the deadline is the date of the last examination
Time Frame
1-year
Title
Time to Response
Description
The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)
Time Frame
1-year
Title
Overall Survival
Description
The time interval between when the subject first received treatment and when death from any cause was recorded. For subjects whose death is not recorded, the deadline is the most recent point in time at which the subject is still alive
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 14-80 years old, male or female; Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement; Expected survival of more than 3 months; AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN; Inactive infection and severe mental illness ECOG score 0~2 According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction >50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion The serum pregnancy test of female subjects must be negative Signed informed consent Exclusion Criteria: Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors; Severe uncontrolled medical disease or active infection (including HIV+); Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding; Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies; Pregnant or nursing women; Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases); The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.) The situation that the researcher judged was not suitable for inclusion
Facility Information:
Facility Name
ChinaPLAGH
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Graduate
Phone
010-66937232
Email
zhaoyu301@126.com
First Name & Middle Initial & Last Name & Degree
Sai Huang, Graduate
Phone
010-66937232
Email
helinahs@qq.com
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Graduate
First Name & Middle Initial & Last Name & Degree
Sai Huang, Graduate

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Low-Dose Decitabine plus anti-PD-1 treatment for relapsed/refractory diffuse large B cell lymphoma with extranodal (dsp. central nervous system) involvement: A phaseⅡclinical trial
Citations:
PubMed Identifier
31039052
Citation
Nie J, Wang C, Liu Y, Yang Q, Mei Q, Dong L, Li X, Liu J, Ku W, Zhang Y, Chen M, An X, Shi L, Brock MV, Bai J, Han W. Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2019 Jun 10;37(17):1479-1489. doi: 10.1200/JCO.18.02151. Epub 2019 Apr 30.
Results Reference
result
PubMed Identifier
30620669
Citation
Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.
Results Reference
result
PubMed Identifier
32187361
Citation
Lacy SE, Barrans SL, Beer PA, Painter D, Smith AG, Roman E, Cooke SL, Ruiz C, Glover P, Van Hoppe SJL, Webster N, Campbell PJ, Tooze RM, Patmore R, Burton C, Crouch S, Hodson DJ. Targeted sequencing in DLBCL, molecular subtypes, and outcomes: a Haematological Malignancy Research Network report. Blood. 2020 May 14;135(20):1759-1771. doi: 10.1182/blood.2019003535.
Results Reference
result
PubMed Identifier
28356247
Citation
Nayak L, Iwamoto FM, LaCasce A, Mukundan S, Roemer MGM, Chapuy B, Armand P, Rodig SJ, Shipp MA. PD-1 blockade with nivolumab in relapsed/refractory primary central nervous system and testicular lymphoma. Blood. 2017 Jun 8;129(23):3071-3073. doi: 10.1182/blood-2017-01-764209. Epub 2017 Mar 29.
Results Reference
result

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Decitabine and Anti-PD-1 in R/R DLBCL

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