RecruitingPhase 1Phase 2NCT05959694

A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .

A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

107 participants

Start Date

Oct 11, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral drug called TQB3909 in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — two closely related blood cancers. The drug is a BCL-2 inhibitor, which works by triggering cancer cells to die. This is a safety and effectiveness trial. **You may be eligible if...** - You are 18 to 75 years old with a confirmed diagnosis of CLL or SLL - You have measurable disease on imaging (for SLL) - Your organ function meets required levels and your general health is acceptable (ECOG 0–1) **You may NOT be eligible if...** - You have CLL/SLL that has spread to the brain or spinal fluid - You have previously received a BCL-2 inhibitor (such as venetoclax) - You had a bone marrow or stem cell transplant recently - You had a blood clot or stroke in the past 6 months - You are pregnant or breastfeeding - You are allergic to allopurinol or benzbromarone (medicines used to prevent tumor lysis syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB3909 tablet

TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.

Locations(25)

Anqing Municipal Hospital

Anqing, Anhui, China

Gansu province Wuwei tumour hospital

Wuwei, Gansu, China

Sun Yat-Sen University Cancer Canter

Guangzhou, Guangdong, China

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, China

Harbin first hospital

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Linyi people's hospital

Linyi, Shandong, China

Tai 'an Central Hospital

Tai’an, Shandong, China

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China

Peace Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Affiliated hospital of southwest medical university

Luzhou, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05959694

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