Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

Sponsor
The Affiliated People's Hospital of Ningbo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05510089
Collaborator
(none)
34
1
1
33
1

Study Details

Study Description

Brief Summary

This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: EAP regimen

The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Drug: Etoposide
D1~D2: 75mg/m^2
Other Names:
  • VP-16
  • Drug: Cytarabine
    D1~D2: 300g/m^2, q12h
    Other Names:
  • Ara-C
  • Drug: PEG-rhG-CSF
    D6: 6mg

    Outcome Measures

    Primary Outcome Measures

    1. % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg. [4 weeks]

      The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10^6/kg.

    Secondary Outcome Measures

    1. % of patients achieving the collection of >5×10^6 CD34+ cells/kg. [4 weeks]

      The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of >5×10^6/kg.

    2. TRAEs [4 weeks]

      Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.

    3. Time from PEG-rhG-CSF mobilization to HSC collection. [4 weeks]

      To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. According to the diagnostic criteria of the Italian transplantation working group, patients with hematological malignancies diagnosed as "confirmed poor mobilization" or "predicted poor mobilization".

    2. Patients with auto-HSCT indication.

    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.

    4. Patients should be within age range of ≥18 and ≤75 years old.

    5. Life expectancy ≥ 3 months.

    6. Patients must be able to sign informed consent.

    Exclusion Criteria:
    1. Patients with severe cardiac, hepatic or renal insufficiency, such as:
    • Cardiac function class II or higher or severe arrhythmia;

    • Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;

    • Serum creatinine clearance rate≤50%.

    1. Patients with active infection.

    2. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.

    3. Women who are pregnant or breastfeeding.

    4. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.

    5. For any other reasons, the patients are believed not suitable for participation in this study by investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Affiliated People's Hospital of Ningbo University. Ningbo Zhejiang China 315101

    Sponsors and Collaborators

    • The Affiliated People's Hospital of Ningbo University

    Investigators

    • Principal Investigator: Ying Lu, The Affiliated People's Hospital of Ningbo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Affiliated People's Hospital of Ningbo University
    ClinicalTrials.gov Identifier:
    NCT05510089
    Other Study ID Numbers:
    • 2022-YAN-019
    First Posted:
    Aug 22, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Affiliated People's Hospital of Ningbo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022