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

Lymphoma Clinical Trial

Official title:

A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905942
• Other study ID #: CSPC-JYL-20150830
• Status: Recruiting
• Phase: Phase 4
• First received: September 14, 2016
• Last updated: September 16, 2016
• Start date: December 2015

Study information

• Verified date: September 2016
• Source: Peking University
• Contact: Jun Zhu, MD
• Phone: +86-10-88196596
• Email: zj[@]bjcancer.org
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• PEG-rhG-CSF
PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 100µg/kg(bw).For patients more than 45kg, 6mg was suggested.
• rhG-CSF
rhG-CSF was given day +1 after transplantation with a dose of 5µg/kg once per day

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to neutrophil engraftment		30days	No