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

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.

Sex

All

Minimum age

14 Years

Maximum age

80 Years

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

• RESULTNie 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. PMID 31039052
• RESULTAnsell 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. PMID 30620669
• RESULTLacy 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. PMID 32187361
• RESULTNayak 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. PMID 28356247