Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
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
The Affiliated People's Hospital of Ningbo University
68 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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.
Eligibility
Inclusion Criteria4
- Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
- Life expectancy ≥ 3 months.
- 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 Criteria11
- 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.
- History of hematopoietic stem cell mobilization.
- Patients with active infection.
- Female subjects who are pregnant or lactating.
- 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.
- Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
Interventions
Day 1\~Day 2: 75mg/m\^2
Day 1\~Day 2: 200mg/m\^2, q12h
Day 6: 6mg
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT05536154