Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies

March 17, 2024 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) as First Line Mobilization Regimen of Hematopoietic Stem Cells in 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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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

Detailed Description

In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.

Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.

Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.

Study Type

Interventional

Enrollment (Estimated)

68

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, 315040
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • 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, 317099
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
        • 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. Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
  3. Life expectancy ≥ 3 months.
  4. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Exclusion Criteria:

  1. Patients with severe cardiac, hepatic or renal insufficiency, such as:

    • Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
    • Serum creatinine clearance rate≤50%;
    • Cardiac function class II or higher or severe arrhythmia.
  2. History of hematopoietic stem cell mobilization.
  3. Patients with active infection.
  4. Female subjects who are pregnant or lactating.
  5. 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, such as unstable heart disease, stroke, rheumatoid arthritis, lupus.
  6. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
  7. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.

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
Day 1~Day 2: 75mg/m^2
Other Names:
  • VP-16
Drug: Cytarabine
Day 1~Day 2: 200mg/m^2, q12h
Other Names:
  • Ara-C
Drug: PEG-rhG-CSF
Day 6: 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
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
% 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
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Time Frame: 4 weeks
4 weeks
The average collection times of EAP scheme
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)

November 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-YAN-030

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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