Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat T Cell or Natural Killer (NK) Cell Lymphoma
Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With T Cell or NK Cell Lymphoma
1 other identifier
interventional
42
1 country
5
Brief Summary
The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation in patients with non-Hodgkin lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 3, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedAugust 25, 2014
August 1, 2014
4.4 years
August 3, 2010
August 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
After 3 years
Secondary Outcomes (4)
Overall survival
After 3 years
Response rate according to the International Working Group criteria
After 2 months
Adverse events
From start of conditioning to discharge
Pharmacogenetic study
After 3 years
Study Arms (1)
BuEAM
EXPERIMENTALBusulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day
Interventions
Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day
Eligibility Criteria
You may qualify if:
- Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin lymphoma
- Patients with histologically confirmed T cell or NK cell lymphoma at diagnosis
- Patients who have not received therapy with high-dose chemotherapy and stem cell transplantation
- Life expectation of at least 3 months
- ECOG performance status ≤ 2
- Adequate hepatic function (serum bilirubin less than 2.0 mg/dL, AST and ALT less than three times the upper normal limit)
- Adequate renal function (serum creatinine less than 2.0 mg/dL).
- Adequate cardiac function (ejection fraction ≥ 45% on MUGA scan or echocardiogram).
- Adequate bone marrow function (ANC ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3).
- All patients are fully informed about the nature and purpose of this study and informed consent should be given before the start of treatment. All patients should fully understand the right of trial abandon without any disadvantage
You may not qualify if:
- Patients with central nervous system involvement of lymphoma
- Patients positive for human immunodeficiency virus
- Pregnant or breast feeding woman
- Young woman without pregnancy test prior to treatment or pregnancy test reveals positive.
- Young woman without a reliable and proper contraceptive method
- Man being not willing to contraception
- Concurrent history of neoplasm other than non-Hodgkin lymphoma with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix cancer).
- History of clinically significant cardiac dysfunction (e.g. congestive heart failure, symptomatic coronary artery disease, medically uncontrolled arrhythmia) or myocardial infarction within 12 months
- A psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
- Significant infection or uncontrolled bleeding
- Enrollment of other clinical trials within 4 weeks prior to treatment
- Any preexisting medical condition of sufficient severity to prevent full compliance with the study
- Patient being not willing to or unable to obey study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Inje Universitycollaborator
- Severance Hospitalcollaborator
- Asan Medical Centercollaborator
- Ulsan University Hospitalcollaborator
Study Sites (5)
Inje University Busan Paik Hospital, Inje University College of Medicine
Busan, 614-735, South Korea
Seoul National University Hospital, Seoul National University College of Medicine
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736, South Korea
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan, 682-714, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-Soo Yoon
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 3, 2010
First Posted
August 10, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2014
Last Updated
August 25, 2014
Record last verified: 2014-08