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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02905942

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: PEG-rhG-CSF Drug: rhG-CSF	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG-rhG-CSF Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.	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.
Active Comparator: rhG-CSF Patients in control group received rhG-CSF day +1 after transplantation.	Drug: rhG-CSF rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day

Arm

Intervention/Treatment

Experimental: PEG-rhG-CSF

Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.

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.

Active Comparator: rhG-CSF

Patients in control group received rhG-CSF day +1 after transplantation.

Drug: rhG-CSF

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

Outcome Measures

Primary Outcome Measures

Time to neutrophil engraftment [30days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with age between 18 and 65 years.
Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
The collected CD34+ cells≥1×10E6/kg.
ECOG score ≤2.
Heart and lung is normal.
Blood creatinine ≤1.5×ULN.
ALT, AST, TBIL ≤2 ×ULN
Not in pregnancy.
Written informed consent are acquired.

Exclusion Criteria:

Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis

Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
LVEF <55%.
Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
Refused to take contraceptive measures during the study period and the subsequent 1 years.
Severe mental or neurological disorders.
Serious heart, lung, central nervous system disorders.
Sickle cell anemia, hemolytic anemia and other hematologic diseases.
Participate in other drugs clinical trials 30 days before the screening.
Other situation that investigators consider as contra-indication for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing		China	100142

Sponsors and Collaborators

Peking University

Investigators

Principal Investigator: Jun Zhu, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jun Zhu, Director, Peking University

ClinicalTrials.gov Identifier:

NCT02905942

Other Study ID Numbers:

CSPC-JYL-20150830

First Posted:

Sep 19, 2016

Last Update Posted:

Sep 19, 2016

Last Verified:

Sep 1, 2016

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Sep 19, 2016