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

Launched by THE AFFILIATED PEOPLE'S HOSPITAL OF NINGBO UNIVERSITY · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with certain blood cancers, specifically those who have difficulty collecting stem cells. The study evaluates a combination of three medications—etoposide, cytarabine, and PEG-rhG-CSF—to see how safe and effective they are in helping patients gather enough stem cells for future treatments. If you are between the ages of 18 and 75 and have been diagnosed with multiple myeloma or lymphoma, and your doctor believes you will have a hard time collecting stem cells, you might be eligible to participate.

If you join the trial, you will receive the EAP treatment, and your doctor will closely monitor your blood cell counts to ensure they meet the necessary standards before collecting your stem cells. It’s important to note that this study is currently recruiting participants, but some individuals, such as those with serious heart or kidney issues, or those who are pregnant or breastfeeding, may not be eligible. Overall, this trial aims to improve the process of stem cell collection for patients facing challenging conditions.

Gender

ALL

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