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

Phase 2

• Conditions: Relapsed / Refractory Follicular Lymphoma
• Interventions: Drug: TQ-B3525

• Registration Number: NCT04324879
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2020-05-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-01
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

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

  4. 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.

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

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

  7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3525 tablet	TQ-B3525	TQ-B3525 tablet administered orally.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) assessed by Independent Review Committee (IRC)	Baseline up to 18 months	Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.

Secondary Outcome Measures

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

Trial Locations

Locations (41)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Luohe Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China

Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, Beijing, China

Fifth Medical Center of General Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The Sixth Medical Center of General Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

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