Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma

Launched by THE AFFILIATED PEOPLE'S HOSPITAL OF NINGBO UNIVERSITY · Jul 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment called EAP (which includes the drugs etoposide, cytarabine, and a special growth factor) to see how well it helps mobilize stem cells in patients with non-Hodgkin's lymphoma. Stem cell mobilization is a process that prepares these cells for transplantation, which can be an important part of treatment. The trial will compare this EAP regimen to standard chemotherapy treatments to find out which is more effective and safe for patients. They are looking for 99 participants who are between 18 and 75 years old and have already responded well to chemotherapy.

To be eligible for the trial, patients must have a diagnosis of non-Hodgkin's lymphoma and be candidates for a stem cell transplant. They should also have good overall health and be able to understand and agree to participate in the study. Participants will be randomly assigned to receive either the EAP treatment or the standard chemotherapy. Throughout the trial, patients can expect regular check-ups and tests to monitor their health and the effectiveness of the treatment. This trial is currently recruiting participants, and it's a great opportunity for those who meet the criteria and wish to contribute to important research in lymphoma treatment.

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with non-Hodgkin's lymphoma before enrollment.
• • Indication for autologous stem cell transplantation (ASCT).
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
• • Achieved partial or better response after multiple courses of chemotherapy.
• • Life expectancy ≥ 3 months.
• • Subjects must be able to understand the protocol and sign the informed consent.
• Exclusion Criteria:
• • Cardiac function class II or higher or cardiac ejection fraction \< 40%.
• • Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).
• • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).
• • Serum creatinine clearance rate ≤ 50%.
• • Patients with active infection.
• • History of prior hematopoietic stem cell mobilization.