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

NCT02905916 | Unknown Phase 4

• 1 other identifier: CSPC-JYL-05-07
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammary Cancer; Lymphoma; Bone Tumour; Gynecological Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia (FN)

  30days after PEG-rhG-CSF administration

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSF DRUG

PEG-rhG-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age between 18 and 70 years.
• Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
• With multi-cycle chemotherapy.
• 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.
• KPS score≥ 70.
• Expected to survive more than 3 months.
• 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.
• Written informed consent are acquired. -

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma; Bone Neoplasms

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jun Zhu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, MD

CONTACT

+86-10-88196596; zj@bjcancer.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

CN (1)