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

NCT04610970 | Unknown Phase 2

• 1 other identifier: TQ-B3525-II-05
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall response rate (ORR) assessed by Investigator

  Baseline up to 18 months

• Progression-free survival (PFS)

  Baseline up to 18 months

• Disease control rate（DCR）

  Baseline up to 18 months

• Overall Survival (OS)

  Baseline up to 24 months

Study Arms (1)

TQ-B3525 tablets

EXPERIMENTAL

TQ-B3525 tablet administered orally.

Drug: TQ-B3525 tablets

Interventions

TQ-B3525 tablets DRUG

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

TQ-B3525 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

TQ-B3525

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yuankai Shi, Doctor

CONTACT

010-87788293; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: January 20, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CN (2)