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

August 22, 2014 updated by: Sung-Soo Yoon, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Recruiting
        • Inje University Busan Paik Hospital, Inje University College of Medicine
        • Contact:
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center, University of Ulsan College of Medicine
        • Contact:
        • Principal Investigator:
          • Je Hwan Lee
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital, Seoul National University College of Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Byoung Kook Kim
        • Sub-Investigator:
          • Seonyang Park
        • Sub-Investigator:
          • Inho Kim
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital, Yonsei University College of Medicine
        • Contact:
      • Ulsan, Korea, Republic of, 682-714
        • Recruiting
        • Ulsan University Hospital, University of Ulsan College of Medicine
        • Contact:
          • Hawk Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: After 3 years
After 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From start of conditioning to discharge
From start of conditioning to discharge
Overall survival
Time Frame: After 3 years
After 3 years
Response rate according to the International Working Group criteria
Time Frame: After 2 months
After 2 months
Pharmacogenetic study
Time Frame: After 3 years
Pharmacogenetic study for predictive or prognostic markers using blood samples
After 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Asan Medical Center
Ulsan University Hospital
Inje University
Severance Hospital

Investigators

  • Principal Investigator: Sung-Soo Yoon, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 8, 2010

First Posted (ESTIMATE)

August 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BuEAM-BCL except for DLBCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin Lymphoma

Clinical Trials on Busulfan, etoposide, cytarabine, and melphalan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe