Relapsed or Refractory Diffuse Large B-cell Lymphoma
Conditions
Interventions
Case series:BEBT-908
Sponsors
Cancer Hospital Chinese Academy Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is willing to sign informed consent form (ICF) after comprehensive understanding; 2. Aged 18 to 75 years old, male and female; 3. The biopsy confirmed diffuse large B Cell Lymphoma; 4. Having a measurable lesion; 5. Refractory or recurrent after treatment with at least 2 systems; 6. ECOG 12 Weeks; 8. The level of organ function must meet the requirements.
Exclusion criteria
Exclusion criteria: 1. Known to be severely allergic to research drugs or any of their excipients; 2. Because research drugs may have genotoxic MUTAGENIC and teratogenic effects, the following subjects should therefore be excluded: A men and women who had not had sperm or egg cells preserved in vitro prior to the trial and who planned to reproduce within five years, unless subsequent studies confirmed Reproductive Safety; b women during pregnancy or lactation; 3. Primary central nervous system lymphoma or lymphoma with central nervous system involvement; 4. Previous transformation of chronic lymphoma (e.g. Richter Syndrome, lymphocyte leukemia, etc.); 5. The presence of other active malignancies that may interfere with this study and require treatment; 6. PRE-TRIAL TREATMENT: (1) received any sustained or intermittent small molecule targeted drug therapy, such as PI3K inhibitors, mTOR inhibitors or HDAC inhibitors, 3 months prior to admission; (2) received autologous Hematopoietic Stem Cell Transplantation; (3) received radiotherapy within 3 months prior to admission that affected the outcome of the study, or local supportive radiotherapy that affected bone marrow function; (4) Bone Marrow suppressive chemotherapy or biological therapy was carried out within 3 weeks before admission (5) Major surgery except tumor biopsy was performed within 4 weeks before admission, or the side effects of the surgery were not stable; (6) Patients received any Colony-stimulating factor therapy (E. G. , CSF3 G-CSF, granulocyte macrophage Colony-stimulating factor GM-CSF) within 2 weeks prior to admission; (7) Within 7 days prior to enrollment, patients received prednisone daily & GT; 10 MG (or other equivalent glucocorticoid); 7. After the previous treatment (chemotherapy or biotherapy) , there was persistent grade 2 or above toxicity (CTCAE V5.0 standard) , which was not stable at the time of admission (except Alopecia); 8. There was a severe infection in the mobile phase above Grade 2(CTCAE V5.0 standard); 9. Coexisting disease: (1) diabetes with poor blood sugar control; (2) Serious Lung Disease (CTCAE V5.0 grade III-IV); (3) serious heart disease; (4) significant kidney or liver dysfunction; (5) poorly controlled active hepatitis B or C disease; (6) known Human Immunodeficiency Virus (HIV) positive; (7) a history of mental illness, a family history of mental illness, or mood disorders as determined by the researcher or psychologist; 10. Combined use of drugs that cause prolonged QT interval or tortuous ventricular Tachycardia; 11. Moderate and strong CYTOCHROME P450(Cyp)3A4 isoenzyme inhibitors or induction therapy were administered 4 weeks before admission; 12. 4 weeks prior to admission, participated in other clinical trials and used research drugs; 13. The researchers judged any condition that was unstable or likely to jeopardize the safety of the subjects and their adherence to the study; 14.the researchers determined that the subjects were not suitable for this regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;TTR;DOR;OS; | — |
Countries
China
Contacts
Public ContactQian Chang-Geng
Guangzhou Bebetter Medicine Technology Co,LTD
Outcome results
None listed