Clinical trial NCT05504408: Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia
Official title: A Retrospective and Prospective Multicenter Observational Study for the Evaluation of Incidence of Systemic Mastocytosis With Associated t(8;21) Acute Myeloid Leukemia in t(8;21) Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Mastocytosis With AHNMD
Acute Myeloid Leukemia With T(8;21)(Q22;Q22)
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia
timeFrame: at 1 year
Secondary outcomes:
measure: Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia
timeFrame: at 1 year
measure: Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia
timeFrame: at 1 year
measure: Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia
timeFrame: at 1 year
measure: Survival Distribution of all the t(8;21) Acute Myeloid Leukemia
timeFrame: at 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
name: Suning Chen, professor
role: PRINCIPAL_INVESTIGATOR
References: