Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL

ABSTRACT

ConditionDiffuse Large B Cell Lymphoma;Relapsed Diffuse Large B-Cell Lymphoma;Refractory Diffuse Large B-Cell Lymphoma

InterventionDrug Sintilimab

Primary outcome:Complete response rate

Criteria
Inclusion Criteria

1. Willingness to provide written informed consent.

2. Age range from 18 to 80 years;

3. Pathologically confirmed CD20+ diffuse large B-cell lymphoma

4. According to Lugano 2014, at least one measurable nodular lesion with a length of
greater than 15 mm, or extranodal lesion greater than 10 mm, lesion on FDG-PET scan
demonstrates uptake);

5. Diffuse large B-cell lymphoma patients failed to first-line rituximab based
chemotherapy including anthracycline or anthracycline

6. Patients are allowed to receive palliative radiotherapy, but the last time
radiotherapy cannot be within 7 days before the first study drug administration;

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

8. Adequate organ function

9. Expectation survival time over 3 months;

Exclusion Criteria

1. History of other malignancy within the past 5 years (except for 1. basal cell
carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had
received treatment for the purpose of cure and had not developed a malignant tumor
with a known active disease in the previous 5 years);

2. Patients who had received other antitumor therapy (including corticosteroid therapy,
immunotherapy) or participated in other clinical studies within 4 weeks before the
start of the enrollment (if patients received small-molecule targeted drug therapy,
they could be included in the study if the drug was discontinued for more than 5
half-lives), or had not recovered from the previous toxicity;

3. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody or other medications
that stimulates or collaboratively inhibits T cell receptors

4. Patients previously received anti-CD20 antibody combined GemOx regimen;

5. Evidence of central nervous system invasion;

6. Patients received systemic treatment of traditional Chinese herb with anti-tumor
indications or immunomodulatory drugs (including thyroxin, interferon and
interleukinin, except for local use to control pleural effusions) within 2 weeks
before first administration;

7. Patients with autoimmune diseases requiring treatment or with a history of syndrome
requiring systemic use of steroid immunosuppressive agents, such as hypophysitis,
pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;

8. Patients received systemic glucocorticoid therapy (excluding nasal spray, inhaled or
other topical glucocorticoids) or any other form of immunosuppressive therapy within 7
days prior to the first administration;

9. Clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not
need drainage effusion or do not significantly increase the effusion after 3 days of
drainage can be enrolled);

10. Patients who have had previous organ transplants (except autologous hematopoietic stem
cell transplants);

11. Patients are allergic to sintilimab, CD20 monoclonal antibody and GemOx regimen

12. Patients has not fully recovered from toxicity and/or complications due to any
intervention prior to initiation of treatment (i.e., = grade 1 or baseline, excluding
fatigue or hair loss);

13. A confirmed history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2
antibody positive);

14. A confirmed history of Novel Coronavirus infection;

15. Patients with hepatitis B (HBV HBsAg positive and HBV-DNA=105), hepatitis C (HCV)
infection (HCV antibody positive and HCV-RNA detectable); And subjects with other
acquired or congenital immune deficiency diseases, including but not limited to
hiv-infected;

16. Patients who received the live vaccine within 4 weeks of the start of the enrollment;

17. Pregnant or lactating women;

18. Patients who have received grade II or above surgery within 3 weeks before enrollment;

19. Patients with significant coagulation abnormality;

20. Other serious, uncontrolled concomitant diseases that may affect protocol compliance
or interfere with results interpretation, including uncontrolled diabetes, or
pulmonary disease (a history of interstitial pneumonia, obstructive pulmonary disease,
and symptomatic bronchospasm);

21. Patients who received the live vaccine within 4 weeks of the start of the enrollment;

22. Severe or uncontrolled infections;

23. Patients with history of severe neurological or psychiatric illness, including
dementia or epilepsy;

24. Patients with drug abuse, medical, psychological or social conditions that may
interfere with the study results or the assessment of the study results;

25. Patients are unsuitable for the enrollment according to investigator's judgement.