MedTrace Logo

PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients

NCT00948090 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2014-07-31

Study results available
· View outcomes & findings →

Summary

This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Conditions

Interventions

DRUG

IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.

Sponsors & Collaborators

Principal Investigators

  • Agnes Elekes, MD · Otsuka Pharmaceutical Development and commercialization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00948090 on ClinicalTrials.gov