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A Study of TQ-B3525 in the Tr...

A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)

Last Updated: 2020-07-01

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-12-31

Brief Summary

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The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.

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Detailed Description

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Conditions

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Relapsed / Refractory Follicular Lymphoma

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. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.

3\. Relapsed / refractory FL. 4. At least one measurable lymph node or extranodal lymphoma lesions. 5. Adequate organ system function. 6. 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 diagnosed and/or treated additional malignancy within 3 years prior to the first administration.

2\. Has a history of immunodeficiency diseases. 3. Has multiple factors affecting oral medication. 4. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

5\. Has received systemic steroid treatment within 7 days before the first administration.

6\. 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.

7\. Has palliative radiation therapy within 4 weeks before the first administration.

8\. Has received surgery, or unhealed wounds within 4 weeks before the first administration.

9\. Has a history of autologous hematopoietic stem cell transplant within 3 months or allogeneic hematopoietic stem cell transplant within 6 months.

10.Has cardiovascular disease ≥grade 2 within 6 months before the first administration.

11\. Has active hepatitis B or C. 12. Has psychotropic substances abuse or a mental disorder. 13.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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