Status:
COMPLETED
Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma
Lead Sponsor:
Zhengzhou University
Conditions:
Relapsed and Refractory
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
14-70 years
Phase:
PHASE4
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 n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03376958
Start Date
January 1 2017
End Date
April 30 2019
Last Update
July 25 2019
Active Locations (1)
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1
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052