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

2022-YAN-019

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.

2022-09-01

2024-05-31

2024-12-31

Recruiting

62

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

2023-10-10