NCT05409547

Brief Summary

Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization (PBSCM) and autologous peripheral blood stem cell transplantation (APBSCT). Primary purpose: Compare the difference between PEG-rhG-CSF and G-CSF in PBSCM. Secondary purpose: Compare the difference between PEG-rhG-CSF and G-CSF in APBSCT.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Typical duration for phase_4

Status
unknown

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

First Submitted

Initial submission to the registry

May 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

May 24, 2022

Last Update Submit

June 13, 2022

Conditions

Granulocyte Colony-stimulating FactorStem Cell Mobilization

Keywords

Hematopoietic stem cell mobilizationHematopoietic stem cell transplantationpegylated granulocyte colony-stimulating factor

Outcome Measures

Primary Outcomes (1)

  • Efficiency of stem cell mobilization

    Count of collected CD34+ cells (CD34+ \> 2×10\^6 /kg will be considered as successful mobilization).

    3years

Secondary Outcomes (1)

  • Time of hematopoietic reconstitution

    3years

Study Arms (2)

PEG-G-CSF

EXPERIMENTAL

6 mg, single dose

Drug: PEG-rhG-CSF

rhG-CSF

ACTIVE COMPARATOR

5 μg/kg, twice a day

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG

PEG-rhG-CSF 6 mg/d (single dose) will be given on the second day after chemotherapy.

Also known as: rhG-CSF
PEG-G-CSFrhG-CSF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;
  • Patients who receive APBSCT voluntarily;
  • Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;
  • Each subject must sign the informed consent from (ICF) to indicate that he/she understands the purposes and procedures of the study, and participates in the study voluntarily. Considering the patient's conditions, if the patient's signature is not conducive to treatment, his/her legal representative will sign the ICF.

You may not qualify if:

  • Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;
  • Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;
  • Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;
  • Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, with drug dependence, with uncontrolled mental illness, or with cognitive dysfunction;
  • Subjects who participate in other similar clinical studies within 3 months;
  • Subjects who are considered as unsuitable for the study by the investigator (e.g., those expected to be unable to adhere to relevant treatment regimen due to financial problems).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Study Officials

  • ning huang, Professor

    professor

    PRINCIPAL INVESTIGATOR

  • kehong bi, Professor

    professor

    STUDY DIRECTOR

Central Study Contacts

ning huang, Professor

CONTACT

13006594815huangninghbsct@sina.com

kehong bi, Professor

CONTACT

13791120813bikehong11@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 8, 2022

Study Start

June 30, 2022

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 16, 2022

Record last verified: 2022-06