A Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma

Phase 2

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Anlotinib Hydrochloride Capsules

• Registration Number: NCT04827004
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study Start: 2021-04
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.

  2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) . 3. Has received at least 2 lines of systemic treatment. 4. At least one measurable lesion in vertical directions(based on Lugano 2014). 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 randomization.

  3. Understood and signed an informed consent form.

Exclusion Criteria

• 1. 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.

  2. Has central nervous system (CNS) invasion. 3. Has received vascular endothelial growth inhibitor, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, anlotinib and so on.

  3. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.

  4. Has a history of immunodeficiency. 6. Has multiple factors affecting oral medication. 7.Has uncontrollable or important cardiovascular disease. 8.Has any severe and/or uncontrolled diseases. 9. Has received surgery, or unhealed wounds within 4 weeks before the first administration.

  5. Has received systemic steroid therapy within 7 days before the first administration.

  6. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  7. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.

  8. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.

  9. Has psychotropic substances abuse or a mental disorder. 15. Has received autologous hematopoietic stem cell transplantation within 3 months before the first administration, or have received allogeneic hematopoietic stem cell transplantation, or have graft-versus-host reaction.

  10. Has received other anti-tumor therapy within 4 weeks before the first administration.

  17.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

  18. Unsuitable for anlotinib hydrochloride.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib Hydrochloride Capsules	Anlotinib Hydrochloride Capsules	This is a multi-target receptor tyrosine kinase inhibitor.

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	up to 48 weeks	Percentage of participants achieving complete response (CR) and partial response (PR).

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 48 weeks	PFS defined as the time from first medication until the first documented progressive disease (PD) or death from any cause.
Overall survival (OS)	up to 48 weeks	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.
Duration of Response (DOR)	up to 48 weeks	DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China