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

Launched by CHINESE PLA GENERAL HOSPITAL · Apr 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination treatment using low-dose Decitabine and an anti-PD-1 medication for patients with relapsed or refractory diffuse large B cell lymphoma, particularly in cases where the cancer has spread to areas outside the lymph nodes, such as the central nervous system. The goal is to see if this treatment can help patients whose lymphoma has not responded to previous therapies.

To participate in the trial, patients need to be between 14 and 80 years old and have a confirmed diagnosis of this type of lymphoma with specific complications. They should be in reasonably good health, meaning they have a good chance of living for more than three months and do not have serious infections or other uncontrolled medical issues. Participants can expect to undergo treatment cycles lasting three weeks, with the option to continue for up to two years, unless their disease worsens, they experience intolerable side effects, or they choose to leave the study. It's important for potential participants to discuss any questions or concerns with their healthcare provider to determine if this trial is a good fit for them.

Gender

ALL

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