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Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

Primary Purpose

Relapsed and Refractory, Diffuse Large B Cell Lymphoma

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Relapsed and Refractory focused on measuring R R DLBCL, ORR, PFS, OS

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free Survival

The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death

Overall Survival

Time from randomization to death for any reason

Full Information

NCT ID

NCT03376958

First Posted

October 27, 2017

Last Updated

July 24, 2019

Sponsor

Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT03376958

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

February 1, 2019 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed and Refractory, Diffuse Large B Cell Lymphoma

Keywords

R R DLBCL, ORR, PFS, OS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apatinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response Rate

Description

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.

Time Frame

up to end of follow-up-phase

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death

Time Frame

up to end of follow-up-phase

Title

Overall Survival

Description

Time from randomization to death for any reason

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Oncology Department of The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32158186

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.

Results Reference

derived

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Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

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