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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin Lymphoma |
Drug: Busulfan, etoposide, cytarabine, and melphalan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma |
- Progression-free survival [ Time Frame: After 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: After 3 years ] [ Designated as safety issue: No ]
- Response rate according to the International Working Group criteria [ Time Frame: After 2 months ] [ 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: | July 2010 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Sung-Soo Yoon | +82-2-2072-3079 | ssysmc@snu.ac.kr |
| Contact: Won Sik Lee | +82-51-890-6407 | drlee112@hanafos.com |
| Korea, Republic of | |
| Inje University Busan Paik Hospital, Inje University College of Medicine | Recruiting |
| Busan, Korea, Republic of, 614-735 | |
| Contact: Won Sik Lee +82-51-890-6407 drlee112@hanafos.com | |
| Principal Investigator: Won Sik Lee | |
| Seoul National University Hospital, Seoul National University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Sung-Soo Yoon +82-2-2072-3079 ssysmc@snu.ac.kr | |
| Contact: Ji-Won Kim +82-11-9010-0427 werbinig@gmail.com | |
| Sub-Investigator: Byoung Kook Kim | |
| Sub-Investigator: Seonyang Park | |
| Principal Investigator: Sung-Soo Yoon | |
| Sub-Investigator: Inho Kim | |
| Severance Hospital, Yonsei University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Jin Seok Kim hemakim@yuhs.ac | |
| Principal Investigator: Jin Seok Kim | |
| Asan Medical Center, University of Ulsan College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Je Hwan Lee jhlee3@amc.seoul.kr | |
| Principal Investigator: Je Hwan Lee | |
| Ulsan University Hospital, University of Ulsan College of Medicine | Recruiting |
| Ulsan, Korea, Republic of, 682-714 | |
| Contact: Hawk Kim | |
| Principal Investigator: Hawk Kim | |
| Principal Investigator: | Sung-Soo Yoon | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Sung-Soo Yoon / Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01178645 History of Changes |
| Other Study ID Numbers: | BuEAM-BCL except for DLBCL |
| Study First Received: | August 3, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Korea: Institutional Review Board |
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 Cytarabine Melphalan Etoposide phosphate Etoposide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013