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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated People's Hospital of Ningbo University
• Treatments: Cytarabine; Etoposide

Criteria

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%.

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