A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT04808570 | Terminated Phase 1

• 1 other identifier: TQ-B3525-Ib/II-06
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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.

Conditions

Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic 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 (6)

• Overall response rate (ORR) assessed by Investigator

  Baseline up to 18 months

• Duration of disease remission (DOR)

  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.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.

You may not qualify if:

• 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.
• \. Has psychotropic substances abuse or a mental disorder;

Sponsors & Collaborators

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

Study Sites (9)

The First Affiliate Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300050, China

Location

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

TQ-B3525

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: June 5, 2021
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-10

Locations

CN (9)