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

October 7, 2023 updated by: Chen Suning, The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia
Time Frame: 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.
at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia
Time Frame: at 1 year
  1. The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%);
  2. The proliferative degree in sections of BM (%);
  3. The ratio of mast cells in BM smear and FCM (%);
  4. The ratio of expression of CD25, CD2, and CD30 in FCM (%);
  5. The quantification of the AML1-ETO gene fusions (%).
at 1 year
Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia
Time Frame: at 1 year
  1. The rate of eligible complete remission (CR) patients(%);
  2. The rate of eligible CR with incomplete hematologic recovery (CRi) patients(%);
  3. The rate of eligible morphologic leukemia-free state (MLFS) patients(%);
  4. The rate of eligible partial remission (PR) patients(%);
  5. The rate of eligible no response (NR) patients(%);
  6. The rate of eligible CR without MRD patients(%);
  7. The rate of eligible overall response rate (ORR) patients(%).
at 1 year
Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia
Time Frame: 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.
at 1 year
Survival Distribution of all the t(8;21) Acute Myeloid Leukemia
Time Frame: at 2 years
  1. Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death;
  2. Leukemia-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.
at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM-AML01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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