Clinical trial NCT06569095: Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry
Official title: Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic Syndromes
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Chinese PLA General Hospital
name: Wuhan TongJi Hospital
First posted: 2024-08-23
Enrollment: 163
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 1 year-cumulative relapse rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Cumulative positive rate of measurable residual disease (MRD) after transplantation
timeFrame: through study completion, an average of 1 year
measure: Disease-free survival (LFS)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
measure: Non-recurrent death (NRM)
timeFrame: through study completion, an average of 1 year
measure: Transplant-related death (TRM)
timeFrame: through study completion, an average of 1 year
measure: Acute graft-versus-host disease (GVHD)
timeFrame: through study completion, an average of 1 year
measure: Chronic graft-versus-host disease (GVHD)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Wuhan
country: China
facility: Wuhan TongJi Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: