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Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With T Cell or NK Cell Lymphoma

Phase 2
15 Years
65 Years
Open (Enrolling)
Non-Hodgkin Lymphoma

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Trial Information

Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With T Cell or NK Cell Lymphoma

High-dose conditioning regimens commonly used in patients with non-Hodgkin lymphoma are BEAM
(BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and
cyclophosphamide), CBV (cyclophosphamide, carmustine, and etoposide), and combination
regimen with total body irradiation. Three-year progression free survival of patients with
non-Hodgkin lymphoma 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 stem cell
transplantation have also been studied with autologous stem cell transplantation for

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.

Inclusion Criteria:

- Patients with a high-intermediate/high risk international prognostic index at a
diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin

- 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

- 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 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 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

After 3 years

Safety Issue:


Principal Investigator

Sung-Soo Yoon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin