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

October 6, 2023 updated by: The Affiliated People's Hospital of Ningbo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Dongyang, Zhejiang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310012
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
      • Hangzhou, Zhejiang, China, 310024
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Huzhou, Zhejiang, China
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
      • Jinhua, Zhejiang, China, 321000
        • Recruiting
        • Jinhua municipal central hospital
        • Contact:
      • Jinhua, Zhejiang, China, 321099
        • Recruiting
        • Jinhua People's Hospital
        • Contact:
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Municipal Central Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315101
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University.
        • Contact:
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
        • Contact:
      • Shaoxing, Zhejiang, China, 312099
        • Recruiting
        • Shaoxing Second Hospital
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. According to the diagnostic criteria of the Italian transplantation working group, patients with multiple myeloma or lymphoma 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%.
  2. Patients with active infection.
  3. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
  4. Women who are pregnant or breastfeeding.
  5. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
  6. For any other reasons, the patients are believed not suitable for participation in this study by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 300mg/m^2, q12h
Other Names:
  • Ara-C
Drug: PEG-rhG-CSF
D6: 6mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of >5×10^6 CD34+ cells/kg.
Time Frame: 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.
4 weeks
TRAEs
Time Frame: 4 weeks
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
4 weeks
Time from PEG-rhG-CSF mobilization to HSC collection.
Time Frame: 4 weeks
To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.
4 weeks
The average collection times of EAP regimen
Time Frame: 4 weeks
4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated People's Hospital of Ningbo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-YAN-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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