Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

NCT ID: NCT03376958

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-04-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients with Relapsed Refractory Diffuse Large B Cell Lymphoma.

Detailed Description

Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2.The investigators have been proceeding this trial to evaluate the efficacy and safety of Apatinib in the patients with relapsed refractory diffuse large B cell lymphoma.

Conditions

Relapsed and Refractory; Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib

Apatinib 500mg once daily makes an initial dose and 28 days made one treatment cycle. All patients took the drug continuously until disease progression, intolerable toxicities, and patient-requested withdrawal. Appropriate supportive care were given.

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib, a novel small molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, have shown remarkable efficacy in many solid cancers. The result of our study presented that apatinib might have a rapid, safe and high efficacy on lymphoma patients.

Interventions

Apatinib

Apatinib, a novel small molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, have shown remarkable efficacy in many solid cancers. The result of our study presented that apatinib might have a rapid, safe and high efficacy on lymphoma patients.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age range 14-70 years old; ECOG performance status 0-2.
• Estimated survival time > 6 months.
• Histological confirmed diffuse large B cell lymphoma.
• Have taken first-line chemotherapy regimen and failed.
• None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal.
• At least one measurable lesion.
• None of other serious diseases, cardiopulmonary function is normal.
• Pregnancy test of women at reproductive age must be negative.
• Patients could be followed up.
• None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
• Volunteers who signed informed consent.

Exclusion Criteria

• Disagreement on blood sample collection.
• Patients allergic of any of drug in this regimen or with metabolic disorder.
• Pregnant or lactating women.
• Serious medical illness likely to interfere with participation.
• Serious infection.
• Primitive or secondary tumors of central nervous system.
• Chemotherapy or radiotherapy contraindication.
• The evidence of CNS metastasis.
• History of peripheral nervous disorder or dysphrenia.
• Patients participating in other clinical trials.
• Patients taking other antitumor drugs.
• Patients estimated to be unsuitable by investigator.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Countries

China

References

Ma X, Li L, Zhang L, Fu X, Li X, Wang X, Wu J, Sun Z, Zhang X, Feng X, Chang Y, Zhou Z, Nan F, Zhang J, Li Z, Zhang M. Apatinib in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma: A Phase II, Open-Label, Single-Arm, Prospective Study. Drug Des Devel Ther. 2020 Jan 22;14:275-284. doi: 10.2147/DDDT.S227477. eCollection 2020.

Reference Type: DERIVED

PMID: 32158186 (View on PubMed)

Other Identifiers

hnslblzlzx2017-1

Identifier Type: -

Identifier Source: org_study_id