Using Etoposide, Cytarabine, and PEG-rhG-CSF to Mobilize Stem Cells in Blood Cancer Patients

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 study is testing a new combination of medications to see if it can help people with lymphoma and multiple myeloma gather their stem cells more effectively for treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated People's Hospital of Ningbo University (Government)
• Drugs / interventions: chemotherapy
• Locations: 14 sites (Dongyang, Zhejiang and 13 other locations)
• Trial ID: NCT05536154 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving etoposide, cytarabine, and PEG-rhG-CSF as a first-line regimen for mobilizing hematopoietic stem cells in patients with lymphoma and multiple myeloma. Eligible participants will receive the EAP regimen, and their blood cell counts will be monitored to determine the optimal time for stem cell collection. The study aims to establish a standardized approach for stem cell mobilization in this patient population, particularly focusing on older patients or those with certain renal conditions.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with lymphoma or multiple myeloma who are eligible for autologous hematopoietic stem cell transplantation.

Not a fit: Patients with severe cardiac, hepatic, or renal insufficiencies, or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the efficiency and safety of stem cell mobilization for patients with hematological malignancies.

How similar studies have performed: Other studies have shown promising results with similar mobilization regimens, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Dongyang, Zhejiang and 13 other locations

• Dongyang People's Hospital — Dongyang, Zhejiang, China (Recruiting)
• Tongde Hospital of Zhejiang Province — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Huzhou central hospital — Huzhou, Zhejiang, China (Recruiting)
• Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China (Recruiting)
• Jinhua People's Hospital — Jinhua, Zhejiang, China (Recruiting)
• Lishui Municipal Central Hospital — Lishui, Zhejiang, China (Recruiting)
• The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)
• Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University — Shaoxing, Zhejiang, China (Recruiting)
• Shaoxing Second Hospital — Shaoxing, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
• Taizhou Central Hospital — Taizhou, Zhejiang, China (Recruiting)
• The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Ying Lu — The Affiliated People's Hospital of Ningbo University
• Study coordinator: Ying Lu

Conditions Lymphoma; Multiple Myeloma; Etoposide; Cytarabine; PEG-rhG-CSF; Hematological Malignancies; Hematopoietic Stem Cell Mobilization