- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178658
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
Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With T Cell or NK Cell Lymphoma
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sung-Soo Yoon
- Phone Number: +82-2-2072-3079
- Email: ssysmc@snu.ac.kr
Study Contact Backup
- Name: Won Sik Lee
- Phone Number: +82-51-890-6407
- Email: drlee112@hanafos.com
Study Locations
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Busan, Korea, Republic of, 614-735
- Recruiting
- Inje University Busan Paik Hospital, Inje University College of Medicine
-
Contact:
- Won Sik Lee
- Phone Number: +82-51-890-6407
- Email: drlee112@hanafos.com
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Seoul, Korea, Republic of, 138-736
- Recruiting
- Asan Medical Center, University of Ulsan College of Medicine
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Contact:
- Je Hwan Lee
- Email: jhlee3@amc.seoul.kr
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Principal Investigator:
- Je Hwan Lee
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Seoul, Korea, Republic of, 110-744
- Recruiting
- Seoul National University Hospital, Seoul National University College of Medicine
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Contact:
- Sung-Soo Yoon
- Phone Number: +82-2-2072-3079
- Email: ssysmc@snu.ac.kr
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Contact:
- Ji-Won Kim
- Phone Number: +82-11-9010-0427
- Email: werbinig@gmail.com
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Sub-Investigator:
- Byoung Kook Kim
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Sub-Investigator:
- Seonyang Park
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Sub-Investigator:
- Inho Kim
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital, Yonsei University College of Medicine
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Contact:
- Jin Seok Kim
- Email: hemakim@yuhs.ac
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Ulsan, Korea, Republic of, 682-714
- Recruiting
- Ulsan University Hospital, University of Ulsan College of Medicine
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Contact:
- Hawk Kim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 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
Study Plan
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
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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
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After 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: From start of conditioning to discharge
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From start of conditioning to discharge
|
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Overall survival
Time Frame: After 3 years
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After 3 years
|
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Response rate according to the International Working Group criteria
Time Frame: After 2 months
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After 2 months
|
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Pharmacogenetic study
Time Frame: After 3 years
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Pharmacogenetic study for predictive or prognostic markers using blood samples
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After 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sung-Soo Yoon, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Melphalan
- Cytarabine
- Busulfan
Other Study ID Numbers
- BuEAM-NK/T
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.
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