Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Allo-HSCT
Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Hematopoietic Stem Cell Transplantation
To assess the value of deep NGS-MRD detection for risk stratification in adult high-risk acute myeloid leukemia (AML) patients, in this prospective, single-center, observational cohort study following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 169 patients will be enrolled, and deep NGS-MRD testing will be performed at approximately +3 months after transplantation. Patients will be stratified into NGS-MRD-positive and NGS-MRD-negative groups based on test results. No investigational interventions will be administered. Follow-up analyses will evaluate the associations between NGS-MRD status and post-transplant relapse and survival.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Erlie Jiang
- 電話番号:+86-15122538106
- メール:jiangerlie@ihcams.ac.cn
研究連絡先のバックアップ
- 名前:Dan Feng
- 電話番号:+86-17863810313
- メール:fengdan@ihcams.ac.cn
研究場所
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300020
- National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
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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
サンプリング方法
調査対象母集団
To assess the risk-stratifying value of deep NGS-MRD detection in high-risk acute myeloid leukemia (AML) patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT), this prospective, single-center, observational cohort study plans to enroll 169 patients. Deep NGS-MRD testing will be performed at approximately +3 months after transplantation.
説明
Inclusion Criteria:
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Age ≥ 18 years;
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Diagnosis as high-risk AML meeting at least one of the following criteria:
- Adverse group according to the 2022 ELN risk classification;
- Failure to achieve molecular remission or MRD positivity before transplantation;
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Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT);
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KPS score ≥ 60;
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Written informed consent obtained from the patient or legal guardian
Exclusion Criteria:
- Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
- Concurrent diagnosis of another malignant neoplasm;
- Poor follow-up compliance or inability to complete NGS testing;
- Other conditions for which the investigator deems the subject ineligible to participate in this trial.
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
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
NGS-MRD AML cohort
This prospective, single-center, observational cohort study plans to enroll 169 high-risk acute myeloid leukemia (AML) patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
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 |
|---|---|---|
|
6-month cumulative incidence of relapse
時間枠:6 months after transplantation
|
Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse. |
6 months after transplantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1 year cumulative incidence of relapse
時間枠:1 year after transplantation
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Calculated from the date of transplantation until the first occurrence of AML relapse. |
1 year after transplantation
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|
2 year cumulative incidence of relapse
時間枠:2 year after transplantation
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Calculated from the date of transplantation until the first occurrence of AML relapse. |
2 year after transplantation
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|
Relapse free survival
時間枠:2 year after transplantation
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Calculated from the date of transplantation until the relapse or death |
2 year after transplantation
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Overall survival
時間枠:2 year after transplantation
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Calculated from the date of transplantation until death |
2 year after transplantation
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Non-relapse mortality
時間枠:2 year after transplantation
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Calculated from the date of transplantation until death without relapse |
2 year after transplantation
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Time interval from NGS-MRD positivity to clinical relapse
時間枠:2 year after transplantation
|
3-months NGS-MRD positivity to clinical relapse |
2 year after transplantation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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
- IIT2026119
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
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