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Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376958
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

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.

Condition or disease Intervention/treatment Phase
Relapsed and Refractory Diffuse Large B Cell Lymphoma Drug: Apatinib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib for Relapsed and Refractory Difuse Large B Cell Lymphoma: an Open-label, Single Armed, Exploratory Study
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376958


Locations
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China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT03376958    
Other Study ID Numbers: hnslblzlzx2017-1
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mingzhi Zhang, Zhengzhou University:
R R DLBCL
ORR
PFS
OS
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action