PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University

Criteria

Inclusion Criteria:

1. Patients with age between 18 and 65 years.

2. Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.

3. The collected CD34+ cells≥1×10E6/kg.

4. ECOG score ≤2.

5. Heart and lung is normal.

6. Blood creatinine ≤1.5×ULN.

7. ALT, AST, TBIL ≤2 ×ULN

8. Not in pregnancy.

9. Written informed consent are acquired.

Exclusion Criteria:

1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.

2. Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.

3. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.

4. LVEF <55%.

5. Allergic to the product or other biological products from genetically engineered Escherichia coli strains.

6. Refused to take contraceptive measures during the study period and the subsequent 1 years.

7. Severe mental or neurological disorders.

8. Serious heart, lung, central nervous system disorders.

9. Sickle cell anemia, hemolytic anemia and other hematologic diseases.

10. Participate in other drugs clinical trials 30 days before the screening.

11. Other situation that investigators consider as contra-indication for this study.

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