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

NCT ID: NCT05504408

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Systemic Mastocytosis with associated t(8;21) AML

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

No interventions assigned to this group

The t(8;21) AML without Systemic Mastocytosis

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.

No interventions assigned to this group

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

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Chen Suning

Director, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suning Chen, professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Locations

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Suning Chen, professor

Role: CONTACT

chensuning@sina.com

+86-13814881746

Facility Contacts

Suning Chen

Role: primary

chensuning@sina.com

13814881746

Other Identifiers

SM-AML01

Identifier Type: -

Identifier Source: org_study_id