BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Busan、大韓民国
- 募集
- Inje University Busan Paik Hospital
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コンタクト：
- Won Sik Lee, Dr. PhD.
- 電話番号：+82-51-890-6407
- メール：wonsik112@gmail.com
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主任研究者：
- Won Sik Lee, M.D. PhD.
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Seoul、大韓民国
- 募集
- Seoul National University Hospital
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主任研究者：
- Sung Soo Yoon, M.D. Ph.D.
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Seoul、大韓民国
- 募集
- Asan Medical Center, University of Ulsan
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主任研究者：
- Je Hwan Lee, M.D. Ph.D.
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Seoul、大韓民国
- 募集
- Yeonsei University Hospital
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主任研究者：
- Jin Seok Kim, M.D. Ph.D.
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Ulsan、大韓民国
- 募集
- Ulsan University Hospital
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主任研究者：
- Hawk Kim, M.D. Ph. D.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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progression-free survival
時間枠：three year
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three year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全生存
時間枠：三年
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三年
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Response rate according to the International Working Group criteria
時間枠：after 2 month
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after 2 month
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有害事象
時間枠：コンディショニング開始から退院まで
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コンディショニング開始から退院まで
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•Pharmacogenetic study
時間枠：After 3 years
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Pharmacogenetic study for predictive or prognostic markers using blood samples
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After 3 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Won Sik Lee, Dr. PhD.、Inje University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BuEAM-DLBCL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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