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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by Inje University
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT01063439
First received: February 4, 2010
Last updated: December 1, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Non Hodgkin's Lymphoma
Drug: Busulfan, Etoposide, Cytarabine, Melphalan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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 Diffuse Large B Cell Lymphoma (DLCBL) Previously Treated With Rituximab Based Regimen

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: three year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: three year ] [ Designated as safety issue: No ]
  • Response rate according to the International Working Group criteria [ Time Frame: after 2 month ] [ 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: January 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   up 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'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
  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: NCT01063439

Contacts
Contact: Won Sik Lee, Dr. PhD. 82-51-890-6407 wonsik112@gmail.com

Locations
Korea, Republic of
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Won Sik Lee, Dr. PhD.    +82-51-890-6407    wonsik112@gmail.com   
Principal Investigator: Won Sik Lee, M.D. PhD.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sung Soo Yoon, M.D. Ph.D.         
Yeonsei University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jin Seok Kim, M.D. Ph.D.         
Asan Medical Center, University of Ulsan Recruiting
Seoul, Korea, Republic of
Principal Investigator: Je Hwan Lee, M.D. Ph.D.         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Principal Investigator: Hawk Kim, M.D. Ph. D.         
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Won Sik Lee, Dr. PhD. Inje University
  More Information

No publications provided

Responsible Party: Won Sik Lee, Inje University Busan Paik Hospital
ClinicalTrials.gov Identifier: NCT01063439     History of Changes
Other Study ID Numbers: BuEAM-DLBCL
Study First Received: February 4, 2010
Last Updated: December 1, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
DLBCL
NHL

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
Melphalan
Cytarabine
Etoposide phosphate
Etoposide
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 26, 2014