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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04827004
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
21
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Anlotinib Hydrochloride Capsules
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Open-label, Single-center, Single-arm Phase II Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Anlotinib Hydrochloride Capsules

This is a multi-target receptor tyrosine kinase inhibitor.

Drug: Anlotinib Hydrochloride Capsules
Anlotinib capsules given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [up to 48 weeks]

    Percentage of participants achieving complete response (CR) and partial response (PR).

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
  1. 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.

  2. 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.
  1. 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.

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

  3. 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.

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

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

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

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

  8. 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.

  9. 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.

  1. Unsuitable for anlotinib hydrochloride.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cancer Hospital Chinese Academy of Medical SciencesBeijingBeijingChina100021

Sponsors and Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04827004
Other Study ID Numbers:
  • ALTN-20-II
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021