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NCT Number: NCT03376958

Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

apatinib

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Overall Survival

    Time frame: up to the date of death or end of follow-up-phase

    Time from randomization to death for any reason

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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