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. (see Contacts and Locations)
Verified July 2011 by Seoul National University Hospital
Sponsor:
Collaborators:
Inje University
Severance Hospital
Asan Medical Center
Ulsan University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01178645
First received: August 3, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Non-Hodgkin Lymphoma
Drug: Busulfan, etoposide, cytarabine, and melphalan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


Further study details as provided by Seoul National University Hospital:

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

Secondary Outcome Measures:
  • 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 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178645

Contacts
Contact: Sung-Soo Yoon +82-2-2072-3079 ssysmc@snu.ac.kr
Contact: Won Sik Lee +82-51-890-6407 drlee112@hanafos.com

Locations
Korea, Republic of
Inje University Busan Paik Hospital, Inje University College of Medicine Recruiting
Busan, Korea, Republic of, 614-735
Contact: Won Sik Lee    +82-51-890-6407    drlee112@hanafos.com   
Principal Investigator: Won Sik Lee         
Seoul National University Hospital, Seoul National University College of Medicine Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sung-Soo Yoon    +82-2-2072-3079    ssysmc@snu.ac.kr   
Contact: Ji-Won Kim    +82-11-9010-0427    werbinig@gmail.com   
Sub-Investigator: Byoung Kook Kim         
Sub-Investigator: Seonyang Park         
Principal Investigator: Sung-Soo Yoon         
Sub-Investigator: Inho Kim         
Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jin Seok Kim       hemakim@yuhs.ac   
Principal Investigator: Jin Seok Kim         
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Je Hwan Lee       jhlee3@amc.seoul.kr   
Principal Investigator: Je Hwan Lee         
Ulsan University Hospital, University of Ulsan College of Medicine Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Hawk Kim         
Principal Investigator: Hawk Kim         
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Severance Hospital
Asan Medical Center
Ulsan University Hospital
Investigators
Principal Investigator: Sung-Soo Yoon Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Sung-Soo Yoon / Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01178645     History of Changes
Other Study ID Numbers: BuEAM-BCL except for DLBCL
Study First Received: August 3, 2010
Last Updated: July 20, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Cytarabine
Melphalan
Etoposide phosphate
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014