Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-60
SponsorPeking University People's Hospital

About this trial

The goal of this observational study is to learn about the predict value of leukemia stem cell for acute myeloid leukemia patients with MLL-rearrangement. The main question it aims to answer is:

• Could be leukemia stem cell used for relapse prediction in acute myeloid leukemia patients with MLL-rearrangement? Leukemia stem cell will be detected at the same time for participants who detected minimal residual disease using bone marrow as part of their regular medical care to answer the question.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation.

Patients who cannot comply with the study.

Trial population

Acute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation will be enrolled.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Detection of leukemia stem cell using multiparameter flow cytometry

    Diagnostic test

    For AML patients with MLL rearrangement enrolled, leukemia stem cell will be detcted at diagnosis and during follow-up. A traditional Minimal residual disease was deteced as normal medical care, simultaneously, leukemia stem cell will be detcted using the sample bone marrow sample.

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: AML patients with MLL rearrangement1 intervention

Trial outcomes

Primary outcomes

1

Relapse

Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites

Time frame
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

Secondary outcomes

1

leukemia-free survival

Leukemia-free survival was defined as survival in continuous complete remission.

Time frame
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
2

overall survival

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

Time frame
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

Other outcomes

Sponsors and contacts

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