NCT02953730

Brief Summary

The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Trial Health

80
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

November 1, 2016

Last Update Submit

November 1, 2016

Conditions

Acute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (3)

  • peak concentration(Cmax)

    1 year

  • elimination half life(t 1/2kel)

    1 year

  • area under the curve(AUC)

    1 year

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL
Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG
PEG-rhG-CSF

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age≤18 years old, gender no limited.
  • Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
  • Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
  • Previously not received radiotherapy.
  • Karnofsky Performance Scores ( KPS)≥60.
  • The expected survival time was \>3 months.
  • Neutropenia or agranulocytosis, no bleeding tendency.
  • No significant cardiac dysfunction or metabolic disease.
  • TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \< 2.5×ULN（upper limit of normal）.
  • BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）\<1.5×ULN.
  • Written informed consent are acquired.

You may not qualify if:

  • With a history of systemic radiotherapy.
  • Infection difficult to control, the body temperature ≥ 38℃.
  • Other situation that investigators consider as contra-indication for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xiaofan Zhu, MD

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 3, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

CN(1)