Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

This study is currently recruiting participants.
Verified July 2011 by Seoul National University Hospital

First Received on August 3, 2010.  
Last Updated on July 20, 2011  
History of Changes
This Clinical Trial Sponsored By: Seoul National University Hospital
Collaborators: Inje University
Severance Hospital
Asan Medical Center
Ulsan University Hospital
Information provided by: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01178645
 

Purpose for Clinical Trial

The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation in patients with non-Hodgkin lymphoma.

Condition Study Intervention Clinical Trial Phase
Non-Hodgkin Lymphoma Drug: Busulfan, etoposide, cytarabine, and melphalan Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Busulfan
Cytarabine
Melphalan
Melphalan hydrochloride
Etoposide
Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures For Clinical Trial:

  • Progression-free survival [ Time Frame: After 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Overall survival [ Time Frame: After 3 years ] [ Designated as safety issue: No ]
  • Response rate according to the International Working Group criteria [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From start of conditioning to discharge ] [ Designated as safety issue: Yes ]
  • Pharmacogenetic study [ Time Frame: After 3 years ] [ Designated as safety issue: Yes ]
    Pharmacogenetic study for predictive or prognostic markers using blood samples

Estimated Enrollment: 42
Study Start Date: July 2010
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: BuEAM

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
Drug: Busulfan, etoposide, cytarabine, and melphalan

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

Detailed Description:

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 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 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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin lymphoma
  • Patients with histologically confirmed B cell lymphoma except for diffuse large B cell lymphoma at diagnosis
  • 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
  • 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 non-Hodgkin with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix

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