Acute Myeloid LeukemiaNCT04858594
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy
An observational study of Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Planned Chemotherapy
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study entry is open to adult patients regardless of gender, race or ethnic background. While there will be every effort to seek out and include women and minority patients, the patient population is expected to be similar to that of other relapsed AML studies at the University Of Minnesota
Who may be able to join
- Age >18 years
- Diagnosis of AML, new diagnosis or relapsed/refractory disease
- Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer
- Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy
- Written informed consent prior to performance of any research related activities
Who cannot join
- Unstable for transfer to the School of Dentistry
- Fever at the time of enrollment
- Documented blood stream infection at the time of enrollment
- Inherited bleeding diathesis
- Periodontitis requiring treatment before starting chemotherapy
- ANC <0.5 x 10^9/L at the time of enrollment
Show all 11Show fewer
- Unstable for transfer to the School of Dentistry
- Fever at the time of enrollment
- Documented blood stream infection at the time of enrollment
- Inherited bleeding diathesis
- Periodontitis requiring treatment before starting chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Read the detailed description
Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy.
Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner).
Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Planned Chemotherapy
- Keywords
- BSI, Periodontitis, AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned ChemotherapyOther
standard oncologic supportive care including antibiotic prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Arm A: with Periodontitis | Patients with periodontitis Receives: Other: Planned Chemotherapy | |
| Arm B: without Periodontitis | Patients without periodontitis Receives: Other: Planned Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Blood stream infections
Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy
Measured: Day 28 of chemotherapy
Secondary outcomes (4)
Number of participants with Neutropenic fever
Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy
Measured: Day 28 of chemotherapy
Number of participants exposed to different antibiotics
Number of participants with antibiotic exposure by day 28 of chemotherapy
Measured: Day 28 of chemotherapy
Length of hospitalization
Number of days the patients were hospitalized
Measured: Day 28 of chemotherapy
Number of participants who died
Number of participants who died by day 28 of chemotherapy
Measured: Day 28 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start4 May 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: PI left and research was stopped
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 Masonic Cancer Center, University of MinnesotaThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858594
- Sponsor's protocol ID
- 2020LS191
- Other IDs
- HM2020-37
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04858594
- Acronym / sponsor ID
- 2020LS191
- Conditions
- Acute Myeloid Leukemia
- Keywords
- BSI, Periodontitis, AML
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left and research was stopped
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Apr 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.
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Detailed description
Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy.
Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner).
Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: with Periodontitis | – | Other: Planned ChemotherapyPatients with periodontitis |
| Arm B: without Periodontitis | – | Other: Planned ChemotherapyPatients without periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study entry is open to adult patients regardless of gender, race or ethnic background. While there will be every effort to seek out and include women and minority patients, the patient population is expected to be similar to that of other relapsed AML studies at the University Of Minnesota
Key inclusion criteria (5 listed)
- Age >18 years
- Diagnosis of AML, new diagnosis or relapsed/refractory disease
- Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer
- Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy
- Written informed consent prior to performance of any research related activities
Key exclusion criteria (11 listed)
- Unstable for transfer to the School of Dentistry
- Fever at the time of enrollment
- Documented blood stream infection at the time of enrollment
- Inherited bleeding diathesis
- Periodontitis requiring treatment before starting chemotherapy
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 |
|---|---|---|
| Planned Chemotherapystandard oncologic supportive care including antibiotic prophylaxis | Other | Arm A: with Periodontitis, Arm B: without Periodontitis |
Primary outcome
Number of participants with Blood stream infections
Time frame: Day 28 of chemotherapy
Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy
4 secondary outcomes
Number of participants with Neutropenic fever
Time frame: Day 28 of chemotherapy
Number of participants exposed to different antibiotics
Time frame: Day 28 of chemotherapy
Length of hospitalization
Time frame: Day 28 of chemotherapy
Number of participants who died
Time frame: Day 28 of chemotherapy
Results and safety
The study was stopped early (reason given: PI left and research was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Armin Rashidi, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
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, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Apr 2022. 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 United States. 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?
The study was stopped early (reason given: PI left and research was stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Blood stream infections (time frame: Day 28 of chemotherapy). 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 11 Apr 2022.