Clinical trial · Observational
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
NCT05504408CI-TRIAL-00070324unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With T(8;21)(Q22;Q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.90 |
| Systemic Mastocytosis With AHNMD | Systemic Mastocytosis with an Associated Myeloid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Systemic Mastocytosis with associated t(8;21) AML
- description
- SM and AML were diagnosed according to the 5th edition WHO classification criteria.
- label
- The t(8;21) AML without Systemic Mastocytosis
- description
- 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.
- label
- OSM (Oligo-mastocytic SM) with associated t(8;21) AML
- description
- 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.
Primary outcomes (1)
- measure
- Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia
- timeFrame
- at 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.