GCB type diffuse large B-cell lymphoma
Conditions
Interventions
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histologically or cytologically diagnosed relapsed and/or refractory diffuse large B-cell lymphoma, patients with GCB type by immunohistochemistry; 3. Progress after receiving first-line or above systemic treatment (at least received CD20 monoclonal antibody treatment); 4. ECOG systemic status (performance status, PS) 0 to 1; 5. Expected survival time >=3 months 6. The patient has at least one measurable lesion that meets IWG2007 standards; 7. Good organ function level; 8. Previously received the following anti-tumor treatments (including radiotherapy, chemotherapy or molecular targeted therapy) until the washout period of this trial >=4 weeks; 9. Did not participate in the clinical trial as a subject within 1 month before participating in this trial; 10. According to the judgment of the researcher, it can comply with the test protocol; 11. Volunteer to participate in this clinical trial, understand the research procedures and be able to sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have used anti-tumor drugs targeting PI3Kd as the target (except those who are out of the group due to intolerance); 2. Other anti-tumor treatments within 4 weeks, including radiotherapy, chemotherapy or molecular targeted therapy; 3. There is a third space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites); 4. Inability to swallow, chronic diarrhea or intestinal obstruction, there are many factors that affect the administration and absorption of drugs; 5. Do not interrupt the use of drugs that may cause QT prolongation (such as antiarrhythmic drugs) during the study; 6. Lymphoma patients with central nervous system (CNS) involvement; 7. People with allergies, or those who are known to have allergies to the components of this medicine; 8. Those who have active viral, bacterial or fungal infections and need treatment (such as pneumonia, etc.); 9. Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure; 10. People with HBV or HCV infection (defined as HbsAg and/or HbcAb positive and HBV DNA copy number >=1x10e4 copy number/ml or >=2000 IU/ml) or acute or chronic active hepatitis C; 11. A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation; 12. Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment; 13. Have uncontrollable or important cardiovascular disease; 14. A positive baseline pregnancy test for pregnant, breastfeeding women or women with childbearing potential; 15. According to the judgment of the investigator, there are accompanying diseases (such as severe hypertension, diabetes, thyroid disease, etc.) that seriously endanger patient safety or affect the completion of the study; 16. Suffer from other uncured malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;efficacy; | — |
Countries
China
Contacts
Public ContactHong Cen
Guangxi Medical University Cancer Hospital
Outcome results
None listed