Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05959694

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) .

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-10-23

107

Participants Needed

25

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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) .

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteered to join the study and signed informed consent form with good compliance
  • Age between 18 and 75 years old at time of consent
  • Eastern Cooperative Oncology Group Performance Status score of 0-1
  • Expected survival period longer than 3 months
  • Diagnosed with CLL or SLL according to 2018 iwCLL guidelines
  • Patients with SLL must have measurable lesions on CT or MRI
  • Female participants of childbearing age agree to use contraceptive measures during the study and for 6 months after
  • Negative pregnancy test within 7 days before enrollment
Not Eligible

You will not qualify if you...

  • Diagnosed with other malignant tumors within 3 years before first medication, except certain treated cancers with long disease-free survival
  • Lymphoma or leukemia involving the central nervous system
  • Previously received allogeneic hematopoietic stem cell transplantation
  • Received autologous hematopoietic stem cell transplantation within 3 months before first medication
  • Unresolved toxic reaction grade 1 or higher from previous treatments
  • Arterial or venous thrombotic events within 6 months before first medication
  • Any serious or uncontrollable diseases
  • Received chemotherapy or radiotherapy within 4 weeks before first medication
  • Received immune checkpoint inhibitors or CAR-T cell therapy within 12 weeks before first medication
  • Received other small molecule anti-tumor treatments within 5 half-lives before first medication
  • Previously treated with BCL-2 inhibitors
  • Received vaccines within 4 weeks before first medication or planned vaccination during study
  • Participated in other antineoplastic drug trials within 4 weeks before first medication
  • Allergic to allopurinol or benzbromarone
  • Investigator judgment excludes due to safety or study completion concerns

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Anqing Municipal Hospital

Anqing, Anhui, China, 246004

Actively Recruiting

2

Gansu province Wuwei tumour hospital

Wuwei, Gansu, China, 733000

Actively Recruiting

3

Sun Yat-Sen University Cancer Canter

Guangzhou, Guangdong, China, 510060

Actively Recruiting

4

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, China, 067400

Actively Recruiting

5

Harbin first hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

6

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150000

Actively Recruiting

7

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

8

Hunan Cancer Hospital

Changsha, Hunan, China, 410029

Actively Recruiting

9

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

10

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215004

Actively Recruiting

11

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

12

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

13

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China, 330029

Actively Recruiting

14

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China, 110000

Actively Recruiting

15

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250063

Actively Recruiting

16

Linyi people's hospital

Linyi, Shandong, China, 276002

Actively Recruiting

17

Tai 'an Central Hospital

Tai’an, Shandong, China, 271000

Actively Recruiting

18

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China, 200050

Actively Recruiting

19

Peace Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China, 460000

Actively Recruiting

20

Affiliated hospital of southwest medical university

Luzhou, Sichuan, China, 646000

Actively Recruiting

21

Mianyang Central Hospital

Mianyang, Sichuan, China, 621000

Actively Recruiting

22

Yibin Second People's Hospital

Yibin, Sichuan, China, 644000

Actively Recruiting

23

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

24

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China, 830054

Actively Recruiting

25

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 315010

Actively Recruiting

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Research Team

J

Jianyong Li, Doctor

CONTACT

K

Keshu Zhou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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