BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)

Inje University (Other)
Overall Status
Unknown status
CT.gov ID

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) including intravenous busulfan instead of BCNU of standard BEAM as a conditioning for autologous stem cell transplantation in patients with NHL.

Condition or Disease Intervention/Treatment Phase
  • Drug: Busulfan, Etoposide, Cytarabine, Melphalan
Phase 2

Detailed Description

Among the high-dose conditioning regimens commonly used in patients with NHL are BEAM (BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and cyclophosphamide), CBV (cyclophosphamide, carmustine, etoposide), and combination regimen with total body irradiation. Three-year progression free survival of patients with NHL received above high-dose chemotherapy followed by autologous stem cell rescue was reported as 40-50%, which is still unsatisfactory.

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.

Study Design

Study Type:
Anticipated Enrollment :
42 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Busulfan, Etoposide, Cytarabine and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With Diffuse Large B Cell Lymphoma (DLCBL) Previously Treated With Rituximab Based Regimen
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Aug 1, 2014
Anticipated Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: 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 Names:
  • BuEAM conditioning
  • Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [three year]

    Secondary Outcome Measures

    1. overall survival [three year]

    2. Response rate according to the International Working Group criteria [after 2 month]

    3. Adverse events [From start of conditioning to discharge]

    4. •Pharmacogenetic study [After 3 years]

      Pharmacogenetic study for predictive or prognostic markers using blood samples

    Eligibility Criteria


    Ages Eligible for Study:
    N/A to 65 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non Hodgkin's lymphoma

    • 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 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 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

    Contacts and Locations


    Site City State Country Postal Code
    1 Inje University Busan Paik Hospital Busan Korea, Republic of
    2 Asan Medical Center, University of Ulsan Seoul Korea, Republic of
    3 Seoul National University Hospital Seoul Korea, Republic of
    4 Yeonsei University Hospital Seoul Korea, Republic of
    5 Ulsan University Hospital Ulsan Korea, Republic of

    Sponsors and Collaborators

    • Inje University


    • Principal Investigator: Won Sik Lee, Dr. PhD., Inje University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    First Posted:
    Feb 5, 2010
    Last Update Posted:
    Dec 2, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2010