Clinical trial NCT04615468: A Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma（PTCL）
Official title: A Single-arm, Open-label, Multi-center, Phase II Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.


Eligibility criteria: 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. Diagnosis of peripheral T-cell lymphoma (PTCL); 4. Has received at least one line systemic treatment and disease progression after the last 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 Criteria:

* 1. Other types of T-cell 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 history of interstitial lung disease; 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 dose; 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 which need drug treatment; 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, left ventricular ejection fraction (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.

Primary outcomes:
measure: Overall response rate (ORR) by Independent Review Committee
timeFrame: up to 6 months
Secondary outcomes:
measure: Overall response rate (ORR) assessed by Investigator
timeFrame: up to 6 months
measure: Duration of response (DOR)
timeFrame: up to 12 months
measure: Progression-free survival (PFS)
timeFrame: up to 6 months
measure: Disease control rate（DCR）
timeFrame: up to 12 months
measure: Overall survival(OS)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: