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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Inje University

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date December 2, 2010
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
progression-free survival [ Time Frame: three year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01063439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
  • overall survival [ Time Frame: three year ]
  • Response rate according to the International Working Group criteria [ Time Frame: after 2 month ]
  • Adverse events [ Time Frame: From start of conditioning to discharge ]
  • •Pharmacogenetic study [ Time Frame: After 3 years ]
    Pharmacogenetic study for predictive or prognostic markers using blood samples
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
overall survival, objective response rate, safety [ Time Frame: three year ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Hodgkin's Lymphoma
Intervention  ICMJE 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
Study Arms 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
Intervention: Drug: Busulfan, Etoposide, Cytarabine, Melphalan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2010)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date February 2015
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01063439
Other Study ID Numbers  ICMJE BuEAM-DLBCL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Won Sik Lee, Inje University Busan Paik Hospital
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Won Sik Lee, Dr. PhD. Inje University
PRS Account Inje University
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP