NCT04615468

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 4, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

October 30, 2020

Last Update Submit

October 30, 2020

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR) by Independent Review Committee

    Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.

    up to 6 months

Secondary Outcomes (5)

  • Overall response rate (ORR) assessed by Investigator

    up to 6 months

  • Duration of response (DOR)

    up to 12 months

  • Progression-free survival (PFS)

    up to 6 months

  • Disease control rate（DCR）

    up to 12 months

  • Overall survival(OS)

    up to 24 months

Study Arms (1)

TQ-B3525 tablets

EXPERIMENTAL

TQ-B3525 tablet administered orally.

Drug: TQ-B3525

Interventions

TQ-B3525DRUG

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

TQ-B3525 tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100083, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

TQ-B3525

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Yuankai Shi, Doctor

CONTACT

010-87788293syuankaipumc@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 4, 2020

Study Start

December 1, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2022

Last Updated

November 4, 2020

Record last verified: 2020-07

Locations

CN(2)