Diffuse Large B Cell Lymphoma, Relapsed and Refractory
Conditions
Keywords
R R DLBCL, ORR, PFS, OS
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 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
DRUGApatinib
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.
Sponsors
Zhengzhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 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 | up to the date of death or end of follow-up-phase | Time from randomization to death for any reason |
Countries
China
Outcome results
None listed