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The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy

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ClinicalTrials.gov Identifier: NCT02905916
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 trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.

Condition or disease Intervention/treatment Phase
Mammary Cancer Lymphoma Bone Tumour Gynecological Tumors Drug: PEG-rhG-CSF Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 217 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018


Arm Intervention/treatment
Experimental: PEG-rhG-CSF Drug: PEG-rhG-CSF



Primary Outcome Measures :
  1. Incidence of febrile neutropenia (FN) [ Time Frame: 30days after PEG-rhG-CSF administration ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with age between 18 and 70 years.
  2. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
  3. With multi-cycle chemotherapy.
  4. With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%,or 10%≤FN risk<20% and has high risk factors associated with FN.
  5. KPS score≥ 70.
  6. Expected to survive more than 3 months.
  7. No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency.
  8. Written informed consent are acquired. -

Exclusion Criteria:

  1. With infection or systemic antibiotic therapy 72h before chemotherapy.
  2. With any abnormal hematopoietic function.
  3. Received transplantation within 3 months.
  4. Suffered from other malignant tumor or brain metastases.
  5. TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
  6. Cr >1.5 ×ULN.
  7. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
  8. Mental or nervous system disorders.
  9. Refused to accept contraceptive measures.
  10. Other situations that investigators consider as contra-indication for this study.

    -


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): NCT02905916


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, MD Beijing Cancer Hospital

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Responsible Party: Jun Zhu, Director, Peking University
ClinicalTrials.gov Identifier: NCT02905916     History of Changes
Other Study ID Numbers: CSPC-JYL-05-07
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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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases