NCT02905942

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
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.
DRUG	rhG-CSF	rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-01
• First posted: 2016-09-19
• Last updated: 2016-09-19

Locations

1 site across 1 country: China