A Study of TQ-B3525 in Subjects With Relapse/Refractory Diffuse Large B-cell Lymphoma （DLBCL）

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

A Single-arm, Open-label, Multicenter, Phase II Clinical Trials of TQ-B3525 in Subjects With Relapse/Refractory Diffuse Large B-cell Lymphoma （DLBCL）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610970
• Other study ID #: TQ-B3525-II-05
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yuankai Shi, Doctor
• Phone: 010-87788293
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory diffuse large B-cell lymphoma who have received at least 2 lines of therapeutic schedules including rituximab. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1.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. Relapsed/refractory Diffuse Large B-cell lymphoma (DLBCL); 4. Has received at least two lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment, either of the treatment should conclude rituximab; 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 Criteria:

• 1. DLBCL transformed from previously diagnosed indolent lymphoma; 2. Has central nervous system violation; 3. Has received other PI3K inhibitors or CAR-T treatments;

4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. Has type I diabetes or uncontrolled type II diabetes; 6.Has history of interstitial lung disease; 7. Has a history of immunodeficiency diseases;

8. Has multiple factors affecting oral medication; 9.Has adverse events caused by previous therapy except alopecia that did not recover to =grade 1; 10. Has received systemic steroid treatment within 7 days before the first administration; 11. 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;

12. Has active infections within 4 weeks before the first administration; 13. Has received surgery, or unhealed wounds within 4 weeks before the first administration;

14. Has a history of autologous hematopoietic stem cell transplant within 3 months;

15. Has a history of allogeneic hematopoietic stem cell transplant; 16. Grade II or higher cardiovascular disease within 6 months before the first administration; 17. QTCF > 480ms, LVEF < 50%; 18. Urinary protein = 2 +, and 24-hour urinary protein quantity>1g within 7 days; 19. Has active hepatitis B or C; 20. Has psychotropic substances abuse or a mental disorder; 21. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• TQ-B3525 tablets
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR) assessed by Independent Review Committee	Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC	Baseline up to 18 months
Secondary	Overall response rate (ORR) assessed by Investigator	Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.	Baseline up to 18 months
Secondary	Progression-free survival (PFS)	PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.	Baseline up to 18 months
Secondary	Disease control rate(DCR)	Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).	Baseline up to 18 months
Secondary	Overall Survival (OS)	OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.	Baseline up to 24 months