Status:
UNKNOWN
A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Relapsed / Refractory Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
Eligibility Criteria
Inclusion
- \- 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
- 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.
- 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.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04324879
Start Date
May 20 2020
End Date
December 1 2022
Last Update
July 1 2020
Active Locations (41)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Beijing Luohe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
4
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China