BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)
NCT ID: NCT01063439
Last Updated: 2010-12-02
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
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2010-01-31
2015-02-28
Brief Summary
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Detailed Description
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Busulfan (Bu)-based preparative regimens, which are commonly used with allogeneic SCT have also been studied with ASCT 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 i.v. busulfan, cyclophosphamide, etoposide was found to be well tolerated and seemed to be effective in patients with aggressive NHL.
Another prospective study for multiple myeloma patients showed that i.v. busulfan and melphalan conditioning regimen made no grade 3-4 non-hematological complication.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BuEAM: Experimental
BuEAM: Experimental 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 Intervention: Drug: Busulfan, etoposide, cytarabine, and melphalan
Busulfan, Etoposide, Cytarabine, Melphalan
Busulfan 3.2 mg/kg/d for 2 days Etoposide 400 mg/m2/d for 2days Cytarabine 1 g/m2 for 2 days Melphalan 140 mg/m2 for 1 day
Interventions
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Busulfan, Etoposide, Cytarabine, Melphalan
Busulfan 3.2 mg/kg/d for 2 days Etoposide 400 mg/m2/d for 2days Cytarabine 1 g/m2 for 2 days Melphalan 140 mg/m2 for 1 day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with histologically confirmed diffuse large B cell lymphoma at diagnosis
* Patients treated with rituximab based regimen previously
* 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 (See Appendix II)
* 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 NHL 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
65 Years
ALL
No
Sponsors
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Inje University
OTHER
Responsible Party
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Inje University Busan Paik Hospital
Principal Investigators
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Won Sik Lee, Dr. PhD.
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Inje University Busan Paik Hospital
Busan, Busan, South Korea
Asan Medical Center, University of Ulsan
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yeonsei University Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Won Sik Lee, Dr. PhD.
Role: primary
Other Identifiers
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BuEAM-DLBCL
Identifier Type: -
Identifier Source: org_study_id