Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Response Rate
    • Time Frame: up to end of follow-up-phase
    • 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.

Secondary Measures

  • Progression-free Survival
    • Time Frame: up to end of follow-up-phase
    • The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
  • Overall Survival
    • Time Frame: up to the date of death or end of follow-up-phase
    • Time from randomization to death for any reason

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhengzhou University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mingzhi Zhang, the director of oncology department of the first affiliated hospital – Zhengzhou University

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