Study Comparing Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy Versus Disease-Specific Chemotherapy for Stem Cell Collection in Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are studying patients with non-Hodgkins lymphoma NHL who need autologous stem cell transplantation to compare two methods of mobilizing hematopoietic stem cells. The trial evaluates the safety and effectiveness of a combination therapy with etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor PEG-rhG-CSF, called the EAP regimen, against disease-specific chemotherapy regimens commonly used for stem cell mobilization. The study is a phase 3, prospective, multicenter, randomized trial involving 99 patients from 16 hospitals. Participants are randomly assigned in a 21 ratio to either the EAP regimen or a disease-specific chemotherapy group. The EAP group receives etoposide and cytarabine on days 1 and 2, PEG-rhG-CSF on day 6, and G-CSF starting on day 9 if white blood cell counts are low, continuing until stem cell collection is complete. The control group receives chemotherapy regimens such as CHOP or Hyper-CVAD tailored to their disease. Researchers monitor the number of CD34 stem cells collected and adverse reactions during the study. Throughout the trial, participants undergo monitoring of stem cell counts, the number of collection attempts, and any side effects related to treatment. The main outcome is the percentage of patients who collect at least 5 million CD34 cells per kilogram in one collection within one month. Secondary outcomes include the proportion achieving at least 2 million CD34 cells, total cells collected, adverse events, and use of plerixafor. The study involves close safety monitoring and follow-up over a one-month period after treatment begins.

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