Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

NCT03376958 | Completed Phase 4

• 1 other identifier: hnslblzlzx2017-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed and Refractory; Diffuse Large B Cell Lymphoma

Keywords

R R DLBCL; ORR; PFS; OS

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  up to end of follow-up-phase

Secondary Outcomes (2)

• Progression-free Survival

  up to end of follow-up-phase

• Overall Survival

  up to the date of death or end of follow-up-phase

Study Arms (1)

Apatinib

EXPERIMENTAL

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

Interventions

Apatinib DRUG

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.

Apatinib

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (1)

• 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.

  PMID: 32158186 DERIVED

MeSH Terms

Conditions

Recurrence; Lymphoma, Large B-Cell, Diffuse

Interventions

apatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: December 19, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: April 30, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

CN (1)