Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Personalized Monitoring of Intravenous Busulfan Dosing for Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation.
This clinical trial studies personalized dose monitoring of busulfan and combination chemotherapy in treating patients with Hodgkin or non-Hodgkin lymphoma undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's peripheral blood or bone marrow and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Monitoring the dose of busulfan may help doctors deliver the most accurate dose and reduce toxicity in patients undergoing stem cell transplant.
PRIMARY OBJECTIVES:
I. To determine the feasibility of real-time therapeutic dose monitoring (TDM) for once
daily intravenously (IV) busulfan administration as part of a preparative regimen for
patients with lymphoma undergoing autologous stem cell transplantation.
SECONDARY OBJECTIVES:
I. To compare the incidence of adverse events including mucositis, liver toxicity, seizures,
and pulmonary toxicity with TDM of once daily IV busulfan compared to historic controls.
II. To compare the 6-month progression-free survival (PFS), with TDM of once daily IV
busulfan compared to historic controls.
III. To determine the proportion of patients who would not have achieved desired busulfan
level with weight-based busulfan dosing and therefore required TDM.
OUTLINE:
Patients receive busulfan intravenously (IV) over 3 hours on days -9 to -6, etoposide IV
continuously over 24-36 hours on days -5 and -4, and cyclophosphamide IV over 4 hours on
days -3 and -2. Patients then undergo autologous stem cell transplant on day 0.
After completion of study treatment, patients are followed up for 6 months.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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