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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05816746

Collaborator

(none)

Enrollment

Location

Arm

34.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma Relapse/Recurrence Extranodal Extension Central Nervous System Lymphoma	Drug: Low-Dose Decitabine plus anti-PD-1	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8	Drug: Low-Dose Decitabine plus anti-PD-1 Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8 Other Names: DP

Arm

Intervention/Treatment

Experimental: Treatment group

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

Drug: Low-Dose Decitabine plus anti-PD-1

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

Other Names:

Outcome Measures

Primary Outcome Measures

Objective Response Rate [1-year]
ORR

Secondary Outcome Measures

Clinical Benefit Rate [1-year]
The total percentage of subjects who achieved minimal response (MR) or above after treatment
Progression Free Survival [1-year]
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 [1-year]
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 [1-year]
The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)
Overall Survival [1-year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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