Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Systemic Mastocytosis with associated t(8;21) AML SM and AML were diagnosed according to the 5th edition WHO classification criteria. |
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| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia [at 1 year]
The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%); The proliferative degree in sections of BM (%); The ratio of mast cells in BM smear and FCM (%); The ratio of expression of CD25, CD2, and CD30 in FCM (%); 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]
The rate of eligible complete remission (CR) patients(%); The rate of eligible CR with incomplete hematologic recovery (CRi) patients(%); The rate of eligible morphologic leukemia-free state (MLFS) patients(%); The rate of eligible partial remission (PR) patients(%); The rate of eligible no response (NR) patients(%); The rate of eligible CR without MRD patients(%); 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]
Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death; Leukemia-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, Age (years) >= 5;
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Newly diagnosed as t(8;21) AML patients according to World Health Organization (WHO) classification;
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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:
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The t(8;21) AML patients with SM have been diagnosed already;
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Patients with drug abuse or long-term alcoholism that affected the evaluation of trial results;
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Patients were deemed unsuitable for enrolment by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Suzhou | Jiangsu | China | 215000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
- Principal Investigator: Suning Chen, professor, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SM-AML01