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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

Phase 2
65 Years
Open (Enrolling)
Non Hodgkin's Lymphoma

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Trial Information

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

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.

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

three year

Safety Issue:


Principal Investigator

Won Sik Lee, Dr. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inje University


Korea: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

February 2015

Related Keywords:

  • Non Hodgkin's Lymphoma
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse