Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

Apatinib for Relapsed and Refractory Difuse Large B Cell Lymphoma: an Open-label, Single Armed, Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376958
• Other study ID #: hnslblzlzx2017-1
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 30, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Relapsed and Refractory

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.	up to end of follow-up-phase
Secondary	Progression-free Survival	The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death	up to end of follow-up-phase
Secondary	Overall Survival	Time from randomization to death for any reason	up to the date of death or end of follow-up-phase