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A Study of TQ-B3525 Tablet in...

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

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Relapsed / Refractory Mantle Cell Lymphoma (MCL)

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQ-B3525 tablet

TQ-B3525 tablet administered orally.

Group Type EXPERIMENTAL

TQ-B3525

Intervention Type DRUG

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

Interventions

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TQ-B3525

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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