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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
rhG-CSF
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG-rhG-CSF

rhG-CSF

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to neutrophil engraftment

Secondary Outcome Measures

Full Information

First Posted
September 14, 2016
Last Updated
September 16, 2016
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT02905942
Brief Title
PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.
Arm Title
rhG-CSF
Arm Type
Active Comparator
Arm Description
Patients in control group received rhG-CSF day +1 after transplantation.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rhG-CSF
Intervention Description
rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day
Primary Outcome Measure Information:
Title
Time to neutrophil engraftment
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 B. 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhu, MD
Phone
+86-10-88196596
Email
zj@bjcancer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Phone
+86-10-88196596
Email
zj@bjcancer.org

12. IPD Sharing Statement

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

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