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

September 16, 2016 updated by: Jun Zhu, Peking University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to neutrophil engraftment
Time Frame: 30days
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-JYL-20150830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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