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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First Affiliated Hospital of Jiaxing University; First Affiliated Hospital of Wenzhou Medical University; First People's Hospital of Hangzhou; Ningbo Medical Center Lihuili Hospital; Second Affiliated Hospital of Wenzhou Medical University; Taizhou Hospital of Zhejiang Province; The First Affiliated Hospital of Zhejiang Chinese Medical University; Wenzhou Central Hospital; Zhejiang Cancer Hospital; Zhejiang Provincial Tongde Hospital
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. Histopathological diagnosis: lymphoma;

2. Age 14 to 65, no gender limitation;

3. ECOG physical condition score was 0~3;

4. Life expectancy >6 months;

5. did not receive recombinant human erythropoietin treatment within 30 days before the first day;

6. 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);

7. Willing to sign the informed consent, can understand and abide by the requirements of the study.

Exclusion Criteria:

1. Active infections requiring intravenous antibiotic treatment and any active malignancies (except lymphomas);

2. Grade III or IV heart failure, uncontrolled hypertension or hypotension, and associated risk or event of thromboembolism;

3. Severe hepatic and renal insufficiency;

4. Patients who have received radiotherapy or chemotherapy for other tumors (except lymphoma) within 6 months;

5. other anemia diseases (such as aplastic anemia, thalassemia, myelodysplastic syndrome, etc.);

6. Inability to understand and follow the study protocol or inability to sign the informed consent.