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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Wuhan TongJi Hospital |
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Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDS-EB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detection of MDS-SC using MFC | Other | The aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year-cumulative relapse rate | Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative positive rate of measurable residual disease (MRD) after transplantation | The proportion of MRD positive patients after treatment. | through study completion, an average of 1 year |
| Disease-free survival (LFS) |
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Inclusion Criteria:
Exclusion Criteria:
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To determine whether there was any difference in relapse between the pre-transplant MRD-positive and -negative groups, the cumulative incidence approach was used with a test for equivalence of CIF for the difference in the Kaplan-Meier estimate of the 1-year CIR. With a planned sample size of 163 AML/MDS patients, 80% power can be achieved against the hypothesis of CIR as 18.3% and 3.6% for cases in the pre-transplant MRD-positive and -negative groups at a significance level of P = 0.05 in Student's one-tailed t-test.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chief physician | Contact | 13520536738 | rmcyj@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| OTHER |
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Disease-free survival was defined as days from transplantation to disease progression after transplantation.
| through study completion, an average of 1 year |
| Overall survival (OS) | Overall survival referred to patients who survived until the final follow-up time point. | through study completion, an average of 1 year |
| Non-recurrent death (NRM) | Non-recurrent mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR. | through study completion, an average of 1 year |
| Transplant-related death (TRM) | Transplant-related death was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation. | through study completion, an average of 1 year |
| Acute graft-versus-host disease (GVHD) | Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut. | through study completion, an average of 1 year |
| Chronic graft-versus-host disease (GVHD) | Chronic GVHD was defined and graded according to the National Institute of Health criteria:[Biol Blood Marrow Transplant,2005,11: 945] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations. | through study completion, an average of 1 year |
| Peking University People's Hospital | Recruiting | Beijing | China |
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| Wuhan TongJi Hospital | Recruiting | Wuhan | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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