Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

Zhengzhou University

Status and phase: Completed; Phase 4

Conditions: Diffuse Large B Cell Lymphoma; Relapsed and Refractory

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03376958

hnslblzlzx2017-1

Details and patient eligibility

About

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 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.

Enrollment: 32 patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Apatinib

Experimental group

Description:

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.

Treatment:

Drug: Apatinib