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
NCT ID: NCT01178658
Last Updated: 2014-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma
NCT01178645
BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)
NCT01063439
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
NCT03794167
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
NCT00948090
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
NCT01969435
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Busulfan (Bu)-based preparative regimens, which are commonly used with allogeneic stem cell transplantation have also been studied with autologous stem cell transplantation for lymphomas.
The development of intravenous busulfan achieved 100% bioavailability bypassing the oral route and increased safety and reliability of generating therapeutic busulfan levels, maximizing efficacy.
Recently, one prospective study showed that a combination conditioning regimen of intravenous busulfan, cyclophosphamide, and etoposide was found to be well tolerated and seemed to be effective in patients with aggressive non-Hodgkin lymphoma. Another prospective study for patients with multiple myeloma showed that intravenous busulfan plus melphalan conditioning regimen made no grade 3-4 non-hematologic complication.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BuEAM
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
Busulfan, etoposide, cytarabine, and melphalan
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Busulfan, etoposide, cytarabine, and melphalan
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
15 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inje University
OTHER
Severance Hospital
OTHER
Asan Medical Center
OTHER
Ulsan University Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sung-Soo Yoon
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sung-Soo Yoon
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inje University Busan Paik Hospital, Inje University College of Medicine
Busan, , South Korea
Seoul National University Hospital, Seoul National University College of Medicine
Seoul, , South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, , South Korea
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hawk Kim
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BuEAM-NK/T
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.