Trial Title:
Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat T Cell or Natural Killer (NK) Cell Lymphoma
NCT ID:
NCT01178658
Condition:
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Cytarabine
Etoposide
Melphalan
Busulfan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Busulfan, etoposide, cytarabine, and melphalan
Description:
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
Arm group label:
BuEAM
Summary:
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.
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.
Criteria for eligibility:
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 T cell or NK 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 lymphoma 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
Gender:
All
Minimum age:
15 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Inje University Busan Paik Hospital, Inje University College of Medicine
Address:
City:
Busan
Zip:
614-735
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Won Sik Lee
Phone:
+82-51-890-6407
Email:
drlee112@hanafos.com
Investigator:
Last name:
Won Sik Lee
Email:
Principal Investigator
Facility:
Name:
Seoul National University Hospital, Seoul National University College of Medicine
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sung-Soo Yoon
Phone:
+82-2-2072-3079
Email:
ssysmc@snu.ac.kr
Contact backup:
Last name:
Ji-Won Kim
Phone:
+82-11-9010-0427
Email:
werbinig@gmail.com
Investigator:
Last name:
Byoung Kook Kim
Email:
Sub-Investigator
Investigator:
Last name:
Seonyang Park
Email:
Sub-Investigator
Investigator:
Last name:
Sung-Soo Yoon
Email:
Principal Investigator
Investigator:
Last name:
Inho Kim
Email:
Sub-Investigator
Facility:
Name:
Severance Hospital, Yonsei University College of Medicine
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin Seok Kim
Email:
hemakim@yuhs.ac
Investigator:
Last name:
Jin Seok Kim
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center, University of Ulsan College of Medicine
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Je Hwan Lee
Email:
jhlee3@amc.seoul.kr
Investigator:
Last name:
Je Hwan Lee
Email:
Principal Investigator
Facility:
Name:
Ulsan University Hospital, University of Ulsan College of Medicine
Address:
City:
Ulsan
Zip:
682-714
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hawk Kim
Investigator:
Last name:
Hawk Kim
Email:
Principal Investigator
Start date:
July 2010
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Inje University
Agency class:
Other
Collaborator:
Agency:
Severance Hospital
Agency class:
Other
Collaborator:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Ulsan University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01178658
