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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diffuse Large B Cell Lymphoma Relapse/Recurrence Extranodal Extension Central Nervous System Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

Low-Dose Decitabine plus anti-PD-1

Intervention Type DRUG

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

Interventions

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Low-Dose Decitabine plus anti-PD-1

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

Intervention Type DRUG

Other Intervention Names

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DP

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No