Acute Myeloid LeukemiaNCT05123352
Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies
An observational study of Acute Myeloid Leukemia and Adult, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens [standard intensive chemotherapy (7+3) or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult, Gut Microbiota
- What is being tested?
- collection of biological samples and clinical data
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2021to Nov 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates will come from patients with newly diagnosed acute myeloid leukemia (AML) in the First Affiliated Hospital of Soochow University from November 2021. Participants should meet the inclusion criteria and not meet exclusion criteria.
Who may be able to join
- Male or female, 65> =Age (years) >= 18;
- Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,2;
- Patients will receive standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy;
- Patients have not received prior therapy for AML (except hydroxycarbamide);
- Liver function: Total bilirubin lower than 3 upper limit of normal (ULN); Aspartate aminotransferase (AST) lower than 3 ULN; Alanine aminotransferase (ALT) lower than 3 ULN (except extramedullary infiltration of leukemia);
- Renal function with creatinine clearance rate (Ccr) higher than 30 ml/min;
- 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
- Acute promyeloid leukemia;
- AML with central nervous system (CNS) infiltration;
- Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) or gastrointestinal surgery;
- HIV infection, Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment;
- Severe and active infection that is difficult to control and cannot tolerate induction therapy;
- Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen;
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- Antibiotic exposure within 30 days before enrollment (carbapenems and/or tigecycline were not included, penicillin, cephalosporins and quinolones could be included)
- Patients reject to participate in the study;
- Patients with severe heart failure (grade 3-4) or patients deemed unsuitable for enrolment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
About this study
Official title: Investigation of the Gut Microbiota Evaluated by Metagenomic Next-Generation Sequencing (mNGS) in Acute Myeloid Leukemia Receiving Standard Intensive Chemotherapy or Bcl-2 Inhibitor-based Targeted Induction Therapy
In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens [standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy].
Read the detailed description
Infections remain one of the major complications during induction therapy of acute myelocytic leukemia (AML). Previous studies have shown that the variation of gut microbiota was an effective predictor for infection development of AML during induction therapy. A growing number of patients with AML received bcl-2 inhibitor-based targeted induction therapy. The investigators assume that there are different effects of bcl-2 inhibitor-based induction therapy on gut microbiota compared with standard intensive chemotherapy (7+3 regimen). Metagenomic Next-Generation Sequencing (mNGS) will be used to perform the investigation of gut microbiota in AML receiving two different induction therapies. And the relationships of gut microbiota with infection complication will be analyzed.
- Conditions
- Acute Myeloid Leukemia, Adult, Gut Microbiota, Infections
- Being tested
- collection of biological samples and clinical data
- Medical subject headings
- Leukemia, Myeloid, Acute, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of biological samples and clinical dataOther
blood and feces samples
| Study group | Role | What they receive |
|---|---|---|
| Standard intensive chemotherapy | Patients with acute myeloid leukemia in this cohort will receive standard induction chemotherapy that combines seven days of cytarabine and three days of anthracycline (7+3 regimen). Receives: Other: collection of biological samples and clinical data | |
| Bcl-2 inhibitor-based targeted therapy | Patients with acute myeloid leukemia in this cohort will receive Bcl-2 inhibitor-based targeted therapy, such as combination of bcl-2 inhibitor plus decitabine/azacitidine with or without sorafenib. Receives: Other: collection of biological samples and clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after induction therapy
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients
Measured: Day 0 i.e.: feces sampling is done at time of diagnosis before induction therapy
Changes in metabolites composition of blood in patients with acute myeloid leukemia before, during and after induction therapy
Metabolomics performed on patients' blood to report the metabolites composition in those patients
Measured: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Secondary outcomes (5)
Changes in immune cells of blood in patients with acute myeloid leukemia before, during and after induction therapy
Immunomicin performed on patients' blood to report the composition of immune cells in those patients
Measured: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Changes of gut permeability markers and microbial compounds of blood in patients with acute myeloid leukemia before, during and after induction therapy
ELISA (in pg/ml)
Measured: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Infection rate during induction therapy
Infection rate of patients with acute myeloid leukemia after two different induction therapy
Measured: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Rate of complete remission
Complete remission after one cycle of induction therapy
Measured: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0
CTCAE (common terminology criteria for adverse event version 4)
Measured: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suning Chen, professor, Principal investigator, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123352
- Sponsor's protocol ID
- AML-GutMicrobiota01
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Gut Microbiota Evaluated by Metagenomic Next-Generation Sequencing (mNGS) in Acute Myeloid Leukemia Receiving Standard Intensive Chemotherapy or Bcl-2 Inhibitor-based Targeted Induction Therapy
- ClinicalTrials.gov ID
- NCT05123352
- Acronym / sponsor ID
- AML-GutMicrobiota01
- Conditions
- Acute Myeloid Leukemia, Adult, Gut Microbiota, Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Nov 2021 (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.
In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens [standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy].
Detailed description
Infections remain one of the major complications during induction therapy of acute myelocytic leukemia (AML). Previous studies have shown that the variation of gut microbiota was an effective predictor for infection development of AML during induction therapy. A growing number of patients with AML received bcl-2 inhibitor-based targeted induction therapy. The investigators assume that there are different effects of bcl-2 inhibitor-based induction therapy on gut microbiota compared with standard intensive chemotherapy (7+3 regimen). Metagenomic Next-Generation Sequencing (mNGS) will be used to perform the investigation of gut microbiota in AML receiving two different induction therapies. And the relationships of gut microbiota with infection complication will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intensive chemotherapy | – | Other: collection of biological samples and clinical dataPatients with acute myeloid leukemia in this cohort will receive standard induction chemotherapy that combines seven days of cytarabine and three days of anthracycline (7+3 regimen). |
| Bcl-2 inhibitor-based targeted therapy | – | Other: collection of biological samples and clinical dataPatients with acute myeloid leukemia in this cohort will receive Bcl-2 inhibitor-based targeted therapy, such as combination of bcl-2 inhibitor plus decitabine/azacitidine with or without sorafenib. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates will come from patients with newly diagnosed acute myeloid leukemia (AML) in the First Affiliated Hospital of Soochow University from November 2021. Participants should meet the inclusion criteria and not meet exclusion criteria.
Key inclusion criteria (8 listed)
- Male or female, 65> =Age (years) >= 18;
- Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,2;
- Patients will receive standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy;
- Patients have not received prior therapy for AML (except hydroxycarbamide);
Key exclusion criteria (9 listed)
- Acute promyeloid leukemia;
- AML with central nervous system (CNS) infiltration;
- Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) or gastrointestinal surgery;
- HIV infection, Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment;
- Severe and active infection that is difficult to control and cannot tolerate induction therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of biological samples and clinical datablood and feces samples | Other | Bcl-2 inhibitor-based targeted therapy, Standard intensive chemotherapy |
Primary outcome
Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after induction therapy
Time frame: Day 0 i.e.: feces sampling is done at time of diagnosis before induction therapy
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients
Changes in metabolites composition of blood in patients with acute myeloid leukemia before, during and after induction therapy
Time frame: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Metabolomics performed on patients' blood to report the metabolites composition in those patients
5 secondary outcomes
Changes in immune cells of blood in patients with acute myeloid leukemia before, during and after induction therapy
Time frame: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Changes of gut permeability markers and microbial compounds of blood in patients with acute myeloid leukemia before, during and after induction therapy
Time frame: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Infection rate during induction therapy
Time frame: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Rate of complete remission
Time frame: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0
Time frame: From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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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 Acute Myeloid Leukemia and Adult, 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 8 inclusion and 9 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 17 Nov 2021. 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 (8613814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after induction therapy (time frame: Day 0 i.e.: feces sampling is done at time of diagnosis before induction therapy). The study lists 2 primary outcomes in all. 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 17 Nov 2021.