Systemic Mastocytosis With AHNMDNCT05504408
Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia
An observational study of Systemic Mastocytosis With AHNMD and Acute Myeloid Leukemia With T(8;21)(Q22;Q22), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Systemic Mastocytosis With AHNMD, Acute Myeloid Leukemia With T(8;21)(Q22;Q22)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Aug 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, 13814881746, chensuning@sina.com
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year
Secondary outcomes (4)
Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia
- The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%);
- The proliferative degree in sections of BM (%);
- The ratio of mast cells in BM smear and FCM (%);
- The ratio of expression of CD25, CD2, and CD30 in FCM (%);
- The quantification of the AML1-ETO gene fusions (%).
Measured: at 1 year
Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia
- The rate of eligible complete remission (CR) patients(%);
- The rate of eligible CR with incomplete hematologic recovery (CRi) patients(%);
- The rate of eligible morphologic leukemia-free state (MLFS) patients(%);
- The rate of eligible partial remission (PR) patients(%);
- The rate of eligible no response (NR) patients(%);
- The rate of eligible CR without MRD patients(%);
- The rate of eligible overall response rate (ORR) patients(%).
Measured: at 1 year
Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia
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.
Measured: at 1 year
Survival Distribution of all the t(8;21) Acute Myeloid Leukemia
- Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death;
- Leukemia-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Mastocytosis With AHNMDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Suning Chen, professor, Principal investigator, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504408
- Sponsor's protocol ID
- SM-AML01
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05504408
- Acronym / sponsor ID
- SM-AML01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia
Time frame: at 1 year
Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia
Time frame: at 1 year
Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia
Time frame: at 1 year
Survival Distribution of all the t(8;21) Acute Myeloid Leukemia
Time frame: at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suning Chen, professor principal investigator
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Mastocytosis With AHNMD and Acute Myeloid Leukemia With T(8;21)(Q22;Q22), run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suning Chen, professor (+86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.