Clinical Trials Directory

Trials / Completed

CompletedNCT01959477

Dose Monitoring of Busulfan and Combination Chemotherapy in Hodgkin or Non-Hodgkin Lymphoma Undergoing Stem Cell Transplant

Personalized Monitoring of Intravenous Busulfan Dosing for Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation.

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
2 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGbusulfanGiven IV
DRUGetoposideGiven IV
DRUGcyclophosphamideGiven IV
PROCEDUREperipheral blood stem cell transplantationUndergo autologous peripheral blood stem cell transplant
PROCEDUREautologous hematopoietic stem cell transplantationUndergo autologous peripheral blood stem cell transplant

Timeline

Start date
2014-03-01
Primary completion
2015-01-01
Completion
2015-04-01
First posted
2013-10-10
Last updated
2015-08-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01959477. Inclusion in this directory is not an endorsement.