NCT01285219

Brief Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim administration has long been established as the standard of care. A pegylated filgrastim was independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. These characters were similar to those of Neulasta. The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the efficacy and safety of a single injection of pegylated filgrastim and daily injections of filgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is that pegylated filgrastim is similarly effective and safe with regular filgrastim.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P50-P75 for phase_3 cancer

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

January 24, 2011

Last Update Submit

January 26, 2011

Conditions

Cancer

Keywords

Granulocyte colony-stimulating factor , recombinantPolyethylene glycolsNeutropeniaDrug therapy, combination

Outcome Measures

Primary Outcomes (1)

  • Protective rate of grade 4 neutropenia

    the rate of ANC keeps above 0.5 × 109 /l through the whole cycle

    21 days

Secondary Outcomes (8)

  • rate of grade 3/4 neutropenia

    21 days

  • time to neutrophil recovery

    21 days

  • incidence of antibiotic administration

    21 days

  • ANC profile

    21 days

  • incidence and severity adverse events

    21 days

  • +3 more secondary outcomes

Study Arms (2)

AOB,pegylated filgrastim to filgrastim

ACTIVE COMPARATOR

patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and filgrastim 5 ug/kg/d in cycle 2

Drug: pegylated filgrastim and filgrastim

BOA,filgrastim to pegylated filgrastim

ACTIVE COMPARATOR

patients received filgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2

Drug: filgrastim and pegylated filgrastim

Interventions

pegylated filgrastim and filgrastimDRUG

patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and filgrastim 5 ug/kg/d in cycle 2

AOB,pegylated filgrastim to filgrastim
filgrastim and pegylated filgrastimDRUG

patients received filgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2

BOA,filgrastim to pegylated filgrastim

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of malignant solid tumours (excluding highly aggressive lymphomas such as lymphoblastic lymphoma and Burkitt lymphoma)
  • chemotherapy naive
  • Karnofsky Performance Status ≥70
  • age 18-70 years; normal white blood cell (WBC) count and platelet count
  • adequate renal, hepatic and cardiac function
  • life expectancy ≥3 months
  • normal bone marrow function

You may not qualify if:

  • history of systematic chemotherapy (including adjuvant therapy)
  • large area radiotherapy (\>25% of bone marrow volume)
  • uncontrolled infection
  • bone marrow involvement
  • pregnancy, lactation
  • history of blood stem cell or organ transplantation
  • antibiotic administration within 72 hours of enrolment
  • long time exposure to glucocorticoids and immunosuppressive agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yang S, He X, Liu P, Zhou S, Dong M, Qin Y, Yang J, Zhang C, Han X, Shi Y. [Duration of filgrastim prophylaxis for chemotherapy-induced neutropenia and its predictors]. Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):69-72. doi: 10.3760/cma.j.issn.0253-3766.2016.01.013. Chinese.

    PMID: 26796810DERIVED

MeSH Terms

Conditions

NeoplasmsNeutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Yuankai Shi, M.D.

    Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 27, 2011

Study Start

January 1, 2006

Primary Completion

May 1, 2007

Study Completion

December 1, 2008

Last Updated

January 27, 2011

Record last verified: 2011-01