Evaluating the incidence of systemic mastocytosis in patients with a specific type of acute myeloid leukemia
A Retrospective and Prospective Multicenter Observational Study for the Evaluation of Incidence of Systemic Mastocytosis With Associated t(8;21) Acute Myeloid Leukemia in t(8;21) Acute Myeloid Leukemia
This study is trying to see how common systemic mastocytosis is in patients who have a specific type of acute myeloid leukemia called t(8;21) and how they respond to standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05504408 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of systemic mastocytosis in patients diagnosed with de novo t(8;21) acute myeloid leukemia (AML). It will collect clinical data from multiple centers over a period from September 2022 to August 2023, focusing on patients with systemic mastocytosis associated with t(8;21) AML and their responses to standard therapy. The study will involve both retrospective and prospective data collection, with follow-up extending until August 2025 to ensure comprehensive observation of patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed patients aged 5 and older with t(8;21) AML according to WHO classification.
Not a fit: Patients who have already been diagnosed with systemic mastocytosis or those deemed unsuitable for enrollment by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the relationship between systemic mastocytosis and t(8;21) AML, potentially leading to improved patient management strategies.
How similar studies have performed: While this study focuses on a specific association, similar observational studies have shown success in identifying patient characteristics and improving treatment outcomes in hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Suning Chen, professor — The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
- Study coordinator: Suning Chen, professor
- Email: chensuning@sina.com
- Phone: +86-13814881746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.