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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Relapsed / Refractory Follicular Lymphoma

Treatments: Drug: TQ-B3525

Study type: Interventional

Funder types: Industry

Identifiers

NCT04324879

TQ-B3525-II-01

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

TQ-B3525 tablet

Experimental group

Description:

TQ-B3525 tablet administered orally.

Treatment:

Drug: TQ-B3525