Status:
TERMINATED
A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
Eligibility Criteria
Inclusion
- Understood and signed an informed consent form; 2. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, Life expectancy ≥ 3 months; 3.Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or pathology, and meets at least one of the criteria for active diseases requiring treatment in IWCLL2008; 4.Has received at least one line of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5.Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
Exclusion
- Has Richter's transformation or prolymphocytic leukemia (PLL)； 2. Has central nervous system violation; 3. Has uncontrolled primary autoimmune cytopenias, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc； 4. Has received other PI3K inhibitors or CAR-T treatments; 5. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 6.Diagnosed as type I diabetes or uncontrollable type II diabetes, or fasting blood glucose\> 8.9 mmol/L or glycosylated hemoglobin (HbA1c)\> 8.5% during the screening period; 7. Has interstitial lung disease or drug-induced interstitial lung disease history; 8. Has a history of immunodeficiency diseases; 9. Has multiple factors affecting oral medication; 10. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 11. Has received systemic steroid treatment within 7 days before the first administration; 12. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 13.Has active infections within 4 weeks before the first administration; 14.Has received surgery, or unhealed wounds within 4 weeks before the first administration; 15. Has a history of autologous hematopoietic stem cell transplant within 3 months; 16. Has a history of allogeneic hematopoietic stem cell transplant; 17. Grade II or higher cardiovascular disease within 6 months before the first administration; 18.QTCF \> 480ms, LVEF \< 50%; 19.Urinary protein ≥ 2 +, and 24-hour urinary protein quantity\>1g within 7 days; 20. Has active hepatitis B or C; 21. Has psychotropic substances abuse or a mental disorder; 22. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
- 21\. Has psychotropic substances abuse or a mental disorder;
Key Trial Info
Start Date :
June 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04808570
Start Date
June 5 2021
End Date
November 22 2023
Last Update
November 29 2023
Active Locations (9)
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1
The First Affiliate Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
3
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
4
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004