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A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04398953
Collaborator
(none)
102
Enrollment
39
Locations
1
Arm
13.4
Anticipated Duration (Months)
2.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: TQ-B3525 tablet

TQ-B3525 tablet administered orally.

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) assessed by Independent Review Committee (IRC) [up to 12 months]

    Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.

Secondary Outcome Measures

  1. Disease control rate（DCR） [up to 12 months]

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

  2. Duration of Response (DOR) [up to 12 months]

    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

  3. Progression-free survival (PFS) [up to 12 months]

    PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.

  4. Overall survival (OS) [up to 18 months]

    OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

  5. Biomarkers [up to 12 months]

    To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Understood and signed an informed consent form; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months; 3. Relapsed / refractory MCL; 4. Has received at least one-line and less than four lines 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.
Exclusion Criteria:
    1. Has central nervous system violation; 2. Has received other PI3K inhibitors; 3. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 4. Has history of interstitial lung disease; 5. Has a history of immunodeficiency diseases; 6. Has multiple factors affecting oral medication; 7. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 8. Has received systemic steroid treatment within 7 days before the first administration; 9. 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; 10. Has palliative radiation therapy within 4 weeks before the first administration; 11. Has active infections within 4 weeks before the first administration; 12. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 13. Has a history of autologous hematopoietic stem cell transplant within 6 months or allogeneic hematopoietic stem cell transplant; 14. QTCF

480ms, LVEF < 50%; 15. Urinary protein ≥ 2 +, and urinary protein quantity >1.0 g in 24 hours within 7 days; 16. Has active hepatitis B or C; 17. Has psychotropic substances abuse or a mental disorder; 18. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Cancer Hospital Hefei Anhui China
2 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China
3 Beijing Boren Hospital Beijing Beijing China
4 Beijing Shijitan Hospital Affiliated to Capital Medical University Beijing Beijing China
5 Cancer Hospital of Chinese Academy of Medical Sciences Beijing Beijing China
6 The Fifth Medical Center of PLA General Hospital Beijing Beijing China
7 The Third Hospital of Peking University Beijing Beijing China
8 Fujian Cancer Hospital Fuzhou Fujian China
9 Union Hospital Affiliated to Fujian Medical University Fuzhou Fujian China
10 The First Affiliated Hospital of Xiamen University Xiamen Fujian China
11 The Second Hospital of Lanzhou University Lanzhou Gansu China
12 Guangdong Provincial People's Hospital Guangzhou Guangdong China
13 Sun Yat-sen University Cancer Center Guangzhou Guangdong China
14 Guangxi Medical University Affiliated Tumor Hospital Nanning Guangxi Zhuang Autonomous Region China
15 Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China
16 Henan Cancer Hospital Zhengzhou Henan China
17 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
18 Hunan Cancer Hospital Changsha Hunan China
19 Huai'an first people's Hospital Huaian Jiangsu China
20 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009
21 Nanjing Drum Tower Hospital Nanjing Jiangsu China
22 Nantong Tumor Hospital Nantong Jiangsu China
23 The First Affiliated Hospital of Suzhou University Suzhou Jiangsu China
24 Jiangxi Cancer Hospital Nanchang Jiangxi China
25 The First Hospital of Jilin University Changchun Jilin China
26 Affiliated Zhongshan Hospital of Dalian University Dalian Liaoning China
27 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China
28 The Second Affiliated Hospital of Dalian Medical University Dalian Liaoning China
29 Affiliated Hospital of Binzhou Medical College Binzhou Shandong China
30 Qingdao Central Hospital Qingdao Shandong China
31 Weifang People's Hospital Weifang Shandong China
32 Weihai Central Hospital Weihai Shandong China
33 Weihai Municipal Hospital Weihai Shandong China
34 Shanghai Tongji Hospital Shanghai Shanghai China
35 Shanxi Provincial People's Hospital Xi'an Shanxi China
36 Hematology Hospital of Chinese Academy of Medical Sciences Tianjin Tianjin China
37 Tianjin Cancer Hospital Tianjin Tianjin China
38 Tianjin Medical University General Hospital Tianjin Tianjin China
39 Tianjing People's Hospital Tianjin Tianjin China

Sponsors and Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04398953
Other Study ID Numbers:
  • TQ-B3525-II-02
First Posted:
May 22, 2020
Last Update Posted:
Sep 11, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell

Study Results

No Results Posted as of Sep 11, 2020