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

September 10, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Ruiyang Xia
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Cancer Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Shijitan Hospital Affiliated to Capital Medical University
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital of Chinese Academy of Medical Sciences
      • Beijing, Beijing, China
        • Not yet recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • The Third Hospital of Peking University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Union Hospital Affiliated to Fujian Medical University
        • Contact:
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • The Second Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Chongyang Wu
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Fourth Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Huaian, Jiangsu, China
        • Not yet recruiting
        • Huai'an First People's Hospital
        • Contact:
        • Principal Investigator:
          • Chunling Wang
      • Nanjing, Jiangsu, China, 210009
      • Nanjing, Jiangsu, China
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Suzhou, Jiangsu, China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Dalian, Liaoning, China
        • Not yet recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Affiliated Hospital of Binzhou Medical College
        • Contact:
        • Principal Investigator:
          • Wenzheng Yu
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Central Hospital
        • Contact:
        • Principal Investigator:
          • Ling Wang
      • Weifang, Shandong, China
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Central Hospital
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Municipal Hospital
        • Contact:
          • xiuzhi Deng
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai Tongji Hospital
        • Contact:
        • Principal Investigator:
          • Bing Xiu
    • Shanxi
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • Shanxi Provincial People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Cancer Hospital
        • Contact:
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Hematology Hospital of Chinese Academy of Medical Sciences
        • Contact:
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjing People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Time Frame: up to 12 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate（DCR）
Time Frame: up to 12 months
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 12 months
Duration of Response (DOR)
Time Frame: up to 12 months
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
up to 12 months
Progression-free survival (PFS)
Time Frame: 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.
up to 12 months
Overall survival (OS)
Time Frame: 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.
up to 18 months
Biomarkers
Time Frame: 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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (ACTUAL)

May 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-B3525-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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