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

NCT05504408 | Unknown

• 1 other identifier: SM-AML01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Mastocytosis With AHNMD; Acute Myeloid Leukemia With T(8;21)(Q22;Q22)

Outcome Measures

Primary Outcomes (1)

• Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia

  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.

  at 1 year

Secondary Outcomes (4)

• Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia

  at 1 year

• Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia

  at 1 year

• Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia

  at 1 year

• Survival Distribution of all the t(8;21) Acute Myeloid Leukemia

  at 2 years

Study Arms (3)

Systemic Mastocytosis with associated t(8;21) AML

SM and AML were diagnosed according to the 5th edition WHO classification criteria.

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.

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.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Candidates will come from patients with newly diagnosed t(8;21) acute myeloid leukemia (AML) in the First Affiliated Hospital of Soochow University and the participated centers from September 2022. Participants should meet the inclusion criteria and not meet exclusion criteria.

You may qualify if:

• Male or female, Age (years) \>= 5;
• Newly diagnosed as t(8;21) AML patients according to World Health Organization (WHO) classification;
• 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.

You may not qualify if:

• The t(8;21) AML patients with SM have been diagnosed already;
• Patients with drug abuse or long-term alcoholism that affected the evaluation of trial results;
• Patients were deemed unsuitable for enrolment by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

RECRUITING

Study Officials

• Suning Chen, professor

  The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suning Chen, professor

CONTACT

+86-13814881746; chensuning@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)