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

Recruiting

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

• Registration Number: NCT05504408
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia	at 1 year	Evaluation of the incidence of systemic mastocytosis associated with t(8;21) AML in patients with de novo t(8;21) AML.; The incidence of systemic mastocytosis associated with t(8;21) AML will be evaluated by means of the number of diagnosis of systemic mastocytosis associated with t(8;21) AML on the number of all diagnoses of de novo t(8;21) AML between September 2022 and August 2023.

Secondary Outcome Measures

Name	Time	Method
Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia	at 1 year	1. The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%); 2. The proliferative degree in sections of BM (%); 3. The ratio of mast cells in BM smear and FCM (%); 4. The ratio of expression of CD25, CD2, and CD30 in FCM (%); 5. The quantification of the AML1-ETO gene fusions (%).
Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia	at 1 year	1. The rate of eligible complete remission (CR) patients(%); 2. The rate of eligible CR with incomplete hematologic recovery (CRi) patients(%); 3. The rate of eligible morphologic leukemia-free state (MLFS) patients(%); 4. The rate of eligible partial remission (PR) patients(%); 5. The rate of eligible no response (NR) patients(%); 6. The rate of eligible CR without MRD patients(%); 7. The rate of eligible overall response rate (ORR) patients(%).
Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia	at 1 year	The outcome of transplant in three groups of patients with systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and OSM with associated t(8;21) AML.
Survival Distribution of all the t(8;21) Acute Myeloid Leukemia	at 2 years	1. Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death; 2. Leukemia-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology; 🇨🇳 Suzhou, Jiangsu, China