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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063439
Recruitment Status : Unknown
Verified August 2010 by Inje University.
Recruitment status was:  Recruiting
First Posted : February 5, 2010
Last Update Posted : December 2, 2010
Information provided by:
Inje University

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
Non Hodgkin's Lymphoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 2010
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : February 2015

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 Name: BuEAM conditioning

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: three year ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: three year ]
  2. Response rate according to the International Working Group criteria [ Time Frame: after 2 month ]
  3. Adverse events [ Time Frame: From start of conditioning to discharge ]
  4. •Pharmacogenetic study [ Time Frame: After 3 years ]
    Pharmacogenetic study for predictive or prognostic markers using blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063439

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Contact: Won Sik Lee, Dr. PhD. 82-51-890-6407

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Korea, Republic of
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Won Sik Lee, Dr. PhD.    +82-51-890-6407   
Principal Investigator: Won Sik Lee, M.D. PhD.         
Asan Medical Center, University of Ulsan Recruiting
Seoul, Korea, Republic of
Principal Investigator: Je Hwan Lee, M.D. Ph.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sung Soo Yoon, M.D. Ph.D.         
Yeonsei University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jin Seok Kim, M.D. Ph.D.         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Principal Investigator: Hawk Kim, M.D. Ph. D.         
Sponsors and Collaborators
Inje University
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Principal Investigator: Won Sik Lee, Dr. PhD. Inje University

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Responsible Party: Won Sik Lee, Inje University Busan Paik Hospital Identifier: NCT01063439     History of Changes
Other Study ID Numbers: BuEAM-DLBCL
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: August 2010

Keywords provided by Inje University:

Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents