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).

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

102

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach

1 country

39 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

1.1 years study duration

First Submitted

Initial submission to the registry

May 19, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed

Last Updated

September 11, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

May 19, 2020

Last Update Submit

September 10, 2020

Conditions

Relapsed / Refractory Mantle Cell Lymphoma (MCL)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

Disease control rate（DCR）
up to 12 months
Duration of Response (DOR)
up to 12 months
Progression-free survival (PFS)
up to 12 months
Overall survival (OS)
up to 18 months
Biomarkers
up to 12 months

Study Arms (1)

TQ-B3525 tablet

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 tablet

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. 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.

You may not qualify if:

\. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.lead

Study Sites (39)

Anhui Cancer Hospital

Hefei, Anhui, China

NOT YET RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Beijing Boren Hospital