Acute Myeloid Leukemia With T(8;21)(Q22;Q22), Systemic Mastocytosis With AHNMD
Conditions
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactSuning Chen, professor
Outcome results
None listed