Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study
RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- Evaluate the efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation (BMT) from a HLA-matched sibling donor, HLA-matched unrelated donor, or HLA-mismatched familial donor, in terms of the frequency of relapse and duration of remission, in patients with acute myeloid leukemia (AML) who have either achieved complete remission (CR1) after induction chemotherapy or who experienced recurrent AML then achieved second CR (CR2) after salvage chemotherapy.
Secondary
- Determine the engraftment, donor chimerism, and secondary graft failure in these patients.
- Assess acute and chronic graft-vs-host disease, immune recovery, and infections in these patients.
- Determine transplantation-related mortality, leukemia-free survival, and overall survival of these patients.
OUTLINE:
Conditioning chemotherapy and allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT): After completion of induction chemotherapy and a resulting complete response (CR1) or salvage chemotherapy resulting in CR2, patients receive 1 of the following conditioning regimens and transplantations determined by age, co-morbidity, and type of available donor:
- 15 to 55 years of age without significant co-morbidity* undergoing HLA-matched sibling bone marrow transplantation (BMT) (BuCy conditioning): Patients receive busulfan IV once daily on days -7 to -4 and cyclophosphamide IV over 1-2 hours once daily on days -3 and -2. Patients then undergo an allogeneic BMT on day 0.
- Older than 55 years or younger than 55 years with co-morbidity* undergoing HLA-matched sibling BMT; patients of any age undergoing HLA-matched unrelated HSCT; and for patients of any age undergoing HLA-mismatched familial donor HSCT (BuFluATG conditioning): Patients receive busulfan IV once daily on days -7 and -6, fludarabine phosphate IV over 30 minutes once daily on days -7 to -2, anti-thymocyte globulin IV over 4 hours once daily on days -3 to -1, and methylprednisolone IV over 30 minutes once daily on days -4 to -1. Patients then undergo either an allogeneic BMT on day 0 or allogeneic peripheral blood hematopoietic stem cell infusions on days 0-1 or 0-2.
NOTE: *Significant co-morbidity is defined as residual fungal or other infections in the lung or other viscera and residual organ toxicities occurring during induction or consolidation chemotherapy.
- GVHD prophylaxis: Patients receive cyclosporine orally or IV over 2-4 hours twice daily beginning on day -1 followed by a taper starting on day 30 (BuFluATG conditioning) or day 60 (BuCy conditioning). Patients also receive methotrexate IV on days 1, 3, and 6 after the last day of donor cell infusion.
- CNS prophylaxis: Patients receive intrathecal (IT) methotrexate once before conditioning regimen. Patients receive IT methotrexate once every 2 weeks for 3 times after transplantation and platelet recovery. Patients also receive leucovorin calcium orally or IV over 4 hours after IT methotrexate and then once every 6 hours for a total of 8 doses after each dose of IT methotrexate.
After completion of study therapy, patients are followed every 3 months for 3 years and then annually.
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
-
-
-
Busan、大韓民国、612-030
- Inje University - Haeundae Paik Hospital
-
Seoul、大韓民国、138-736
- Asan Medical Center - University of Ulsan College of Medicine
-
-
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) meeting 1 of the following criteria:
- Achieved complete response (CR1) after induction chemotherapy
- Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT
- No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17)
Must have a donor available meeting one of the following criteria:
- HLA-matched sibling of 65 years or younger
- 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR
- HLA-mismatched family member (offspring, parents, haploidentical sibling)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin < 2.0 mg/dL
- AST < 3 times the upper limit of normal
- Creatinine < 2.0 mg/dL
- Ejection fraction > 40% on MUGA scan
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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 |
---|---|
実験的:transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
Efficacy of the treatment measured in terms of frequency of relapse and duration of remission
時間枠:up to 2 years after transplantation
|
duration of CR, leukemia recurrence
|
up to 2 years after transplantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Engraftment
時間枠:up to 35 days after transplantation
|
achievement of neutrophil count over 500/ul
|
up to 35 days after transplantation
|
Acute and chronic graft-versus-host disease
時間枠:up to 100 days for acute GVHD and up to 2 years for chronic GVHD
|
up to 100 days for acute GVHD and up to 2 years for chronic GVHD
|
|
Treatment-related mortality
時間枠:up to 2 years after transplantation
|
up to 2 years after transplantation
|
|
Leukemia-free survival and overall survival
時間枠:up to 2 years after transplantation
|
up to 2 years after transplantation
|
協力者と研究者
スポンサー
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
- 11q23 (MLL) 異常を伴う成人急性骨髄性白血病
- t(16;16)(p13;q22)を伴う成人急性骨髄性白血病
- 寛解期の小児急性骨髄性白血病
- 再発性成人急性骨髄性白血病
- 寛解期の成人急性骨髄性白血病
- 成人急性巨核芽球性白血病 (M7)
- 成人急性低分化型骨髄性白血病 (M0)
- 成人急性単芽球性白血病 (M5a)
- 成人急性単球性白血病 (M5b)
- 成熟を伴う成人急性骨髄芽球性白血病(M2)
- 成熟していない成人急性骨髄芽球性白血病 (M1)
- 成人急性骨髄単球性白血病 (M4)
- 成人赤白血病 (M6a)
- 成人純粋赤血球性白血病 (M6b)
- 小児急性骨髄性白血病の再発
- 小児急性赤白血病(M6)
- 小児急性巨核球性白血病 (M7)
- 小児急性低分化型骨髄性白血病 (M0)
- 未成熟の小児急性骨髄芽球性白血病 (M1)
- 成熟を伴う小児急性骨髄芽球性白血病 (M2)
- 小児急性骨髄単球性白血病 (M4)
- 小児急性単芽球性白血病 (M5a)
- 小児急性単球性白血病 (M5b)
- del(5q)を伴う成人急性骨髄性白血病
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000659891
- AMC-UUCM-2009-0579
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。