Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia
調査の概要
状態
条件
詳細な説明
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia.
In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect.
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：yajing huang
- 電話番号：+8615811031508
- メール：yajing_huang@163.com
研究連絡先のバックアップ
- 名前：mei guo
- 電話番号：+8615811031508
- メール：15811031508@163.com
研究場所
-
-
Beijing
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Beijing、Beijing、中国
- 募集
- The Fifth Medical Center of PLA General Hospital
-
コンタクト：
- yajing huang
- 電話番号：+8615811031508
- メール：yajing_huang@163.com
-
コンタクト：
- mei guo
- 電話番号：+8615811031508
- メール：15811031508@163.com
-
-
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 must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- Patients have not been treated before.
- Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
- Patients must have a HLA mismatched donor who should be able to provide informed consent.
- All genders and races are eligible.
- ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
- By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
- Donors must be able to safely undergo leukapheresis.
Exclusion Criteria:
- received operation 4 weeks before randomization
- acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
- active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
- occurred stroke or intracranial hemorrhage within 6 months before randomization.
- Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
- There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
- Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
- Any situation processed by the PI that will be damaged to the patients safety.
- Patients and / or authorized family member refuse to sign the consent.
- attend other clinical researchers in 3 months.
- Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
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：MST for unfit
Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy. Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses. |
HLA-mismatched donor peripheral stem cell infusion
他の名前：
azacytidine 50-75mg/m2
他の名前：
Venetoclax 100-300mg/d ×3d，400mg 4-28d
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the remission rate
時間枠：2month
|
①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram:
absolute neutrophil count of more than 1.0×109/L，platelets of >100×109/L.
③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
|
2month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease Free Survival
時間枠：2 year
|
Measured from complete remission to the date of death or the date of last follow-up examination;
|
2 year
|
|
Overall Survival
時間枠：2 year
|
measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;
|
2 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
treatment-related mortality
時間枠：2 year
|
Early mortality: death within 4 weeks after initiation of induction therapy
|
2 year
|
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 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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