NCT05504408

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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)

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-08-17
• Last updated: 2023-10-10

Locations

1 site across 1 country: China