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

The Affiliated People's Hospital of Ningbo University

Status: Enrolling

Conditions: Hematological Malignancy

Treatments: Drug: Etoposide; Drug: Cytarabine; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT05510089

2022-YAN-019

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

EAP regimen

Experimental group

Description:

The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Treatment:

Drug: Etoposide

Drug: PEG-rhG-CSF

Drug: Cytarabine