PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
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|ClinicalTrials.gov Identifier: NCT00948090|
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
Experimental: IV Busulfan
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
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.
- Number of Progression Events in 2 Years. [ Time Frame: 2 years ]The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.
- Number of Death Events in 2 Years. [ Time Frame: 2 years ]The time of overall survival was defined as the time from transplantation to death of all causes.
- Number of Transplant-related Death Events Until Day 100. [ Time Frame: Day 100 ]Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.
- Overall Response Rate [ Time Frame: Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination) ]The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948090
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|Study Director:||Agnes Elekes, MD||Otsuka Pharmaceutical Development and commercialization|