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

Phase 2

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma; Relapse/Recurrence; Extranodal Extension; Central Nervous System Lymphoma
• Interventions: Drug: Low-Dose Decitabine plus anti-PD-1

• Registration Number: NCT05816746
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Study Start: 2023-05-15
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Low-Dose Decitabine plus anti-PD-1	Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	1-year	ORR

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Rate	1-year	The total percentage of subjects who achieved minimal response (MR) or above after treatment
Time to Response	1-year	The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)
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
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

Trial Locations

Locations (1)

ChinaPLAGH; 🇨🇳 Beijing, Beijing, China