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

Diffuse Large B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816746
• Other study ID #: DP in R/R DLBCL-P01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Recurrence
• Relapse/Recurrence

Intervention

Drug:
• Low-Dose Decitabine plus anti-PD-1
Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8

Locations

Country	Name	City	State
China	ChinaPLAGH	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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 i — View 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 Haematolog — View 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/b — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	ORR	1-year
Secondary	Clinical Benefit Rate	The total percentage of subjects who achieved minimal response (MR) or above after treatment	1-year
Secondary	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	1-year
Secondary	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	1-year
Secondary	Time to Response	The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)	1-year
Secondary	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	1-year