Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia

Soochow University

Status: Enrolling

Conditions: Systemic Mastocytosis With AHNMD; Acute Myeloid Leukemia With T(8;21)(Q22;Q22)

Study type: Observational

Funder types: Other

Identifiers

NCT05504408

SM-AML01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 3 patient groups

Systemic Mastocytosis with associated t(8;21) AML

Description:

SM and AML were diagnosed according to the 5th edition WHO classification criteria.

The t(8;21) AML without Systemic Mastocytosis

Description:

The t(8;21) AML patients do not have associated Systemic Mastocytosis according to the 5th edition WHO classification criteria and no AML1-ETO clone was detected in mast cells.

OSM (Oligo-mastocytic SM) with associated t(8;21) AML

Description:

The t(8;21) AML patients do not have associated Systemic Mastocytosis according to the 5th edition WHO classification criteria, but AML1-ETO clones were detected in mast cells.