Clinical trial NCT05816746: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Relapse/Recurrence
Extranodal Extension
Central Nervous System Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 1-year
Secondary outcomes:
measure: Clinical Benefit Rate
timeFrame: 1-year
measure: Progression Free Survival
timeFrame: 1-year
measure: Duration of Remission
timeFrame: 1-year
measure: Time to Response
timeFrame: 1-year
measure: Overall Survival
timeFrame: 1-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: ChinaPLAGH
state: Beijing
Study officials:
References:
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.
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.
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.
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.