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NCT Number: NCT06569095

Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Myelodysplastic syndromes;
  • Between 15 and 70 years old;
  • Subjects are able to provide written informed consent.

Exclusion criteria

  • Subjects who cannot comply with the study;
  • Patient has severe cardiac (ejection fraction <50%), hepatic (total bilirubin >34μmol/L, ALT, AST >2x upper limit of normal) or renal (blood creatinine >130μmol/L) disease；
  • Uncontrolled serious infection;
  • Other conditions that do not tolerate transplantation or other therapies.

Treatment and study plan

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.

Primary outcomes

  1. 1 year-cumulative relapse rate

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Cumulative positive rate of measurable residual disease (MRD) after transplantation

    Time frame: through study completion, an average of 1 year

    The proportion of MRD positive patients after treatment.

  2. Disease-free survival (LFS)

    Time frame: through study completion, an average of 1 year

    Disease-free survival was defined as days from transplantation to disease progression after transplantation.

  3. Overall survival (OS)

    Time frame: through study completion, an average of 1 year

    Overall survival referred to patients who survived until the final follow-up time point.

  4. Non-recurrent death (NRM)

    Time frame: through study completion, an average of 1 year

    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.

  5. Transplant-related death (TRM)

    Time frame: through study completion, an average of 1 year

    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.

  6. Acute graft-versus-host disease (GVHD)

    Time frame: through study completion, an average of 1 year

    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.

  7. Chronic graft-versus-host disease (GVHD)

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

chief physician

CONTACT

[email protected]

13520536738

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Chinese PLA General Hospital
  • Peking University First Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan TongJi Hospital

Registry information

Official study title

Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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