Clinical Study the Efficacy and Safety of Rh-EPO in the Treatment of Anemia in Lymphoma

NCT04910594 | Unknown Phase 3

• 1 other identifier: 2021-0135
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of lymphoma and anemia is high and the clinical harm is great.However, it has not yet attracted enough clinical attention, and domestic rHuEPO (trade name: Ebio).Shenyang Sansheng Pharmaceutical Co., Ltd.) for lymphoma and anemia patients are less clinical studies.Therefore, a prospective, open-label, multicenter clinical study of recombinant human erythropoietin in the treatment of anemia in patients with lymphoma is planned to analyze the efficacy and safety of recombinant human erythropoietin in patients with lymphoma and anemia, so as to determine the clinical benefits of recombinant human erythropoietin in patients with lymphoma and anemia.

Conditions

Lymphoma; Anemia

Keywords

lymphoma; anemia; recombinant human erythropoietin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin response rate of subjects during treatment.

  A hemoglobin response was defined as an increase in hemoglobin levels of ≥ 1.0 g/dL from baseline during 2 or more consecutive assessments (2 weeks apart) without red blood cell infusion.

  up to 20weeks

Secondary Outcomes (1)

• The time of the first hemoglobin response

  up to 20weeks

Interventions

recombinant human erythropoietin DRUG

To determine the efficacy and safety of recombinant human erythropoietin in improving anemia in patients with lymphoma, and to improve the quality of life and the efficacy of chemotherapy in patients with lymphoma.

Also known as: EPO

Eligibility Criteria

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

You may qualify if:

• Histopathological diagnosis: lymphoma;
• Age 14 to 65, no gender limitation;
• ECOG physical condition score was 0\~3;
• Life expectancy \>6 months;
• did not receive recombinant human erythropoietin treatment within 30 days before the first day;
• Complete liver and kidney function (creatinine ≦1.5\*ULN, BUN≦1.5\*ULN, ALT≦2\*ULN, AST≦2\*ULN, total bilirubin ≦1.5\*ULN;ULN: upper limit of normal value);
• Willing to sign the informed consent, can understand and abide by the requirements of the study.

You may not qualify if:

• Active infections requiring intravenous antibiotic treatment and any active malignancies (except lymphomas);
• Grade III or IV heart failure, uncontrolled hypertension or hypotension, and associated risk or event of thromboembolism;
• Severe hepatic and renal insufficiency;
• Patients who have received radiotherapy or chemotherapy for other tumors (except lymphoma) within 6 months;
• other anemia diseases (such as aplastic anemia, thalassemia, myelodysplastic syndrome, etc.);
• Inability to understand and follow the study protocol or inability to sign the informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First People's Hospital of Hangzhou: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Wenzhou Central Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Anemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• wenbin qian

  2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wenbin qian

CONTACT

+86 13605801032; qwb@zju.edu.cn

xibin xiao

CONTACT

+86 13858015535; xiaoxibinzju@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 2, 2021
• Study Start: April 1, 2021
• Primary Completion: February 14, 2023
• Study Completion: April 1, 2023
• Last Updated: August 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: up to ten years
• Access Criteria: by pubmed

Locations

CN (1)