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Trial Title:
Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia
NCT ID:
NCT05504408
Condition:
Systemic Mastocytosis With AHNMD
Acute Myeloid Leukemia With T(8;21)(Q22;Q22)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Mastocytosis
Mastocytosis, Systemic
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The observational study aimed at evaluating the incidence of systemic mastocytosis
associated with t(8;21) AML in patients with de novo t(8;21) AML and their responses to
first induction, and the prognosis from standard therapy.
Detailed description:
This is a multicenter, retrospective and prospective, observational study that aims to
collect clinical information on patients with systemic mastocytosis associated with
t(8;21) AML from September 2022 to August 2023. No intervention is expected.
The purpose of this study is to identify and characterize the patients with systemic
mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and
OSM (Oligo-mastocytic SM) with associated t(8;21) AML.
In order to estimate the incidence of systemic mastocytosis associated with t(8;21) AML,
a survey will be sent every month to all participating sites to collect the number of all
diagnoses of systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without
systemic mastocytosis, and OSM with associated t(8;21) AML. All patients will be followed
until August 2025 in order to have at least 2 years of observation.
Criteria for eligibility:
Study pop:
Candidates will come from patients with newly diagnosed t(8;21) acute myeloid leukemia
(AML) in the First Affiliated Hospital of Soochow University and the participated centers
from September 2022.
Participants should meet the inclusion criteria and not meet exclusion criteria.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female, Age (years) >= 5;
2. Newly diagnosed as t(8;21) AML patients according to World Health Organization (WHO)
classification;
3. Patients who sign the informed consent must have the ability to understand and be
willing to participate in the study and sign the informed consent.
Exclusion Criteria:
1. The t(8;21) AML patients with SM have been diagnosed already;
2. Patients with drug abuse or long-term alcoholism that affected the evaluation of
trial results;
3. Patients were deemed unsuitable for enrolment by the investigator.
Gender:
All
Minimum age:
5 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen
Phone:
13814881746
Email:
chensuning@sina.com
Start date:
September 1, 2022
Completion date:
August 31, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504408
