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

Study Overview
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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.

Official Title
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A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)

Conditions
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Relapsed / Refractory Follicular Lymphoma

Intervention / Treatment
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* Drug: TQ-B3525


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3525 tablet<br>TQ-B3525 tablet administered orally. | Drug: TQ-B3525<br>* TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) assessed by Independent Review Committee (IRC) | Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC. | Baseline up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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. | Baseline up to 18 months | 
| Overall response rate (ORR) assessed by investigator | Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator. | Baseline up to 18 months | 
| Disease control rate（DCR） | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | Baseline up to 18 months | 
| Overall Survival (OS) | 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. | Baseline up to 24 months | 
| Disease control rate (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | Baseline up to 18 months | 
| Safety | AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability. | Baseline up to 18 months | 
| Biomarkers | To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients. | Baseline up to 18 months |