Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.
調査の概要
状態
条件
詳細な説明
OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine whether the treatment-related mortality can be limited to less than 20% in patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients.
OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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New Jersey
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Paterson、New Jersey、アメリカ、07503
- St. Joseph's Hospital and Medical Center
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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
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No cytogenetic evidence of persistent leukemia if cytogenetics performed
PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed At least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior post-remission therapy for second remission
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：なし
- 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：Autologous stem cell transplantation
Patients receive consolidation chemotherapy followed by autologous stem cell transplantation
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10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed
他の名前：
1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.
2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4
他の名前：
40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant
For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation
Infusion on Day 0
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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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無病生存
時間枠：2年
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2年
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協力者と研究者
捜査官
- スタディチェア：Charles Linker, MD、University of California, San Francisco
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CALGB-9620
- U10CA031946 (米国 NIH グラント/契約)
- CLB-9620
- CDR0000064734 (レジストリ識別子：NCI Physician Data Query)
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