Status:
UNKNOWN
Clinical Study the Efficacy and Safety of Rh-EPO in the Treatment of Anemia in Lymphoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
First People's Hospital of Hangzhou
Zhejiang Provincial Tongde Hospital
Conditions:
Lymphoma
Anemia
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
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 Pharma...
Detailed Description
Anemia is a common complication of malignant lymphoma.Approximately 30-40% of lymphoma patients develop anemia before chemotherapy begins \[1\].Common clinical manifestations of anemia include fatigue...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04910594
Start Date
April 1 2021
End Date
April 1 2023
Last Update
August 11 2021
Active Locations (1)
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1
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, China