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

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ClinicalTrials.gov Identifier: NCT02905942
Recruitment Status : Unknown
Verified September 2016 by Jun Zhu, Peking University.
Recruitment status was:  Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. Time to neutrophil engraftment [ Time Frame: 30days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905942


Contacts
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Contact: Jun Zhu, MD +86-10-88196596 zj@bjcancer.org

Locations
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China
Peking University Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Jun Zhu, MD    +86-10-88196596    zj@bjcancer.org   
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Jun Zhu Beijing Cancer Hospital

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Responsible Party: Jun Zhu, Director, Peking University
ClinicalTrials.gov Identifier: NCT02905942     History of Changes
Other Study ID Numbers: CSPC-JYL-20150830
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases