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

• Sponsor: Peking University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02905916
• Collaborator: (none)
• Enrollment: 217
• Location: 1
• Arm: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 217 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of febrile neutropenia (FN) [30days after PEG-rhG-CSF administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing		China	100142

Sponsors and Collaborators

• Peking University

Investigators

• Principal Investigator: Jun Zhu, MD, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Zhu, Director, Peking University
• ClinicalTrials.gov Identifier: NCT02905916
• Other Study ID Numbers: CSPC-JYL-05-07
• First Posted: Sep 19, 2016
• Last Update Posted: Sep 19, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 19, 2016