Clinical trial NCT03376958: Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma
Official title: Apatinib for Relapsed and Refractory Difuse Large B Cell Lymphoma: an Open-label, Single Armed, Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsed and Refractory
Diffuse Large B Cell Lymphoma
Keywords: R R DLBCL
ORR
PFS
OS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 32
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to end of follow-up-phase
Secondary outcomes:
measure: Progression-free Survival
timeFrame: up to end of follow-up-phase
measure: Overall Survival
timeFrame: up to the date of death or end of follow-up-phase
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
citation: Ma X, Li L, Zhang L, Fu X, Li X, Wang X, Wu J, Sun Z, Zhang X, Feng X, Chang Y, Zhou Z, Nan F, Zhang J, Li Z, Zhang M. Apatinib in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma: A Phase II, Open-Label, Single-Arm, Prospective Study. Drug Des Devel Ther. 2020 Jan 22;14:275-284. doi: 10.2147/DDDT.S227477. eCollection 2020.