- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615468
A Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma(PTCL)
October 30, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Single-arm, Open-label, Multi-center, Phase II Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules.
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
78
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 Locations
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Beijing
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Beijing, Beijing, China, 100083
- Cancer Hospital, Chinese Academy of Medical Sciences
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Shanghai
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Shanghai, Shanghai, China, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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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. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. Diagnosis of peripheral T-cell lymphoma (PTCL); 4. Has received at least one line systemic treatment and disease progression after the last 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. Other types of T-cell lymphoma; 2. Has central nervous system violation; 3. Has received other PI3K inhibitors or CAR-T treatments; 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. Has type I diabetes or uncontrolled type II diabetes; 6. Has history of interstitial lung disease; 7. Has history of interstitial lung disease; 8. Has multiple factors affecting oral medication; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received systemic steroid treatment within 7 days before the first dose; 11. 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; 12. Has active infections which need drug treatment; 13. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. Has a history of autologous hematopoietic stem cell transplant within 3 months; 15. Has a history of allogeneic hematopoietic stem cell transplant; 16. Grade II or higher cardiovascular disease within 6 months before the first administration; 17. QTCF > 480ms, left ventricular ejection fraction (LVEF)<50%; 18. Urinary protein ≥ 2 +, and 24-hour urinary protein quantity>1g within 7 days; 19. Has active hepatitis B or C; 20. Has psychotropic substances abuse or a mental disorder; 21.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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQ-B3525 tablets
TQ-B3525 tablet administered orally.
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TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) by Independent Review Committee
Time Frame: up to 6 months
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Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) assessed by Investigator
Time Frame: up to 6 months
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Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
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up to 6 months
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Duration of response (DOR)
Time Frame: up to 12 months
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DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
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up to 12 months
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Progression-free survival (PFS)
Time Frame: up to 6 months
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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.
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up to 6 months
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Disease control rate(DCR)
Time Frame: up to 12 months
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Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
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up to 12 months
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Overall survival(OS)
Time Frame: up to 24 months
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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.
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up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
October 31, 2021
Study Completion (Anticipated)
October 31, 2022
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
October 30, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQ-B3525-II-04
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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The Lymphoma Academic Research OrganisationCompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaFrance, Belgium
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Millennium Pharmaceuticals, Inc.CompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaUnited States, France, Italy, Poland, United Kingdom, Belgium, Germany, Spain, Belarus, Israel, Portugal, Bulgaria, Turkey, Canada, New Zealand, Peru, Brazil, Russian Federation, Chile, Puerto Rico, Australia, Austria, Hungary, Nether... and more
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University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
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Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
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Karyopharm Therapeutics IncTerminatedCutaneous T-cell Lymphoma (CTCL) | Peripheral T-cell Lymphoma (PTCL)Australia, Singapore
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BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
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SciTech Development, LLCRush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingAngioimmunoblastic T-cell Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma | Follicular T-Cell Lymphoma | Nodal Peripheral T-Cell Lymphoma...United States
Clinical Trials on TQ-B3525
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingRelapsed or Refractory Lymphoma or Advanced CancerChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingDiffuse Large B-cell LymphomaChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownRelapsed / Refractory Mantle Cell Lymphoma (MCL)China
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownRelapsed / Refractory Follicular LymphomaChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial Cancer, Cervical Cancer and Ovarian CancerChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.TerminatedRelapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingNonsmall-cell Lung CancerChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownHR-positive, HER2-negative and PIK3CA Mutation Advanced Breast CancerChina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting