A Open-label, Single-center, Single-arm Phase II Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country30 target enrollmentApril 2021

ConditionsDiffuse Large B-cell Lymphoma

InterventionsAnlotinib Hydrochloride Capsules

DrugsAnlotinib Hydrochloride Capsules

Overview

Phase: Phase 2
Intervention: Anlotinib Hydrochloride Capsules
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Overall response rate (ORR)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single-center, single-arm study to evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules in subjects with diffuse large B-cell lymphoma.

Registry

clinicaltrials.gov

Start Date

April 2021

End Date

December 31, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
•Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) .
•Has received at least 2 lines of systemic treatment.
•At least one measurable lesion in vertical directions(based on Lugano 2014). 5.Adequate organ system function.
•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 randomization.
•Understood and signed an informed consent form.

Exclusion Criteria

•DLBCL transformed from indolent lymphoma (such as FL), primary testicular DLBCL, primary central nervous system lymphoma, mixed lymphoma (such as B cell lymphoma that cannot be classified between HL and DLBCL) Tumor, etc.), Richter's transformed DLBCL.
•Has central nervous system (CNS) invasion.
•Has received vascular endothelial growth inhibitor, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, anlotinib and so on.
•Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
•Has a history of immunodeficiency.
•Has multiple factors affecting oral medication. 7.Has uncontrollable or important cardiovascular disease. 8.Has any severe and/or uncontrolled diseases.
•Has received surgery, or unhealed wounds within 4 weeks before the first administration.
•Has received systemic steroid therapy within 7 days before the first administration.
•Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
•Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.