At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 207 enrolled
Drug / intervention
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)drug
Likely dose
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) 1400mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects With Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 29, 2009·Updated Jul 31, 2014
In Brief
A Phase 2 clinical trial evaluating IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) for Lymphoma. Completed, enrolled 207 participants across 42 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesCanada, United States
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartJan 2010
Primary CompletionMay 2013
Study CompletionJun 2013
TodayJul 2026
First PostedJul 29, 2009
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.9 years ago
Interventions
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)drug
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.