Combination treatment for stem cell mobilization in blood cancer patients

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 study is testing a new combination treatment to help blood cancer patients gather enough stem cells for their treatment when they might struggle to do so on their own.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated People's Hospital of Ningbo University (Government)
• Locations: 12 sites (Dongyang, Zhejiang and 11 other locations)
• Trial ID: NCT05510089 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 for mobilizing hematopoietic stem cells in patients with hematological malignancies who are predicted to have poor mobilization. It is a single-arm, multicenter exploratory study where all eligible participants will receive the treatment and their CD34+ cell and white blood cell counts will be monitored. Once the collection criteria are met, hematopoietic stem cell collection will commence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with multiple myeloma or lymphoma diagnosed as having poor mobilization.

Not a fit: Patients with severe organ insufficiencies, active infections, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve stem cell mobilization in patients with hematological malignancies, potentially leading to better treatment outcomes.

How similar studies have performed: While this approach is exploratory, similar combinations have shown promise in previous studies, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Dongyang, Zhejiang and 11 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)
• Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University — Shaoxing, Zhejiang, China (Recruiting)
• Shaoxing Second Hospital — Shaoxing, Zhejiang, China (Recruiting)
• Taizhou Central Hospital — Taizhou, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)

Study contacts

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

Conditions Hematological Malignancy; Etoposide; Cytarabine; PEG-rhG-CSF; Hematological Malignancies; Hematopoietic Stem Cell Mobilization