Acute Myeloid LeukemiaNCT06323590
Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study
An observational study of Acute Myeloid Leukemia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML.
Who may be able to join
- Adult male or female, age ≥18
- Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
- Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
- Cardiac function: Ejection fraction >50-55%
- Adequate organ function for receipt for induction chemotherapy
- Patients with HIV and Hepatitis B or C should have controlled disease.
- Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
Who cannot join
- Any other active malignancy requiring treatment or with expected survival ≤1 year.
- Recipients of prior allogeneic stem cell transplant.
- Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
- Patients with active CNS disease
- Patients with APL
- Received any investigational drugs within the 14 days prior to the first day of induction
- Pregnant and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot
The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.
Read the detailed description
This will be a pilot study that will include patients with AML receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). All patients will have a planned mid-induction bone marrow assessment as standard of care. All patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. Patients with complete remission (CR) will proceed to consolidation chemotherapy as determined by the treating investigator. Patients with refractory disease will proceed to further therapy as determined by the treating investigator. All patients will be followed for long-term outcomes.
- Conditions
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
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 |
|---|---|---|
| Cohort A | Patients with AML, receiving standard induction chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of complete remission
rates of complete remission in consecutive patients with AML, receiving standard induction chemotherapy, without intervening on the results of the mid-induction bone marrow biopsy.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start2 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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 University of Alabama at BirminghamThe 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
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Jamy, University of Alabama at Birmingham
- Investigators
- Omer Jamy, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323590
- Sponsor's protocol ID
- UAB 2372
- Other IDs
- UAB
- Status last verified
- May 2026
- First submitted
- 14 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot
- ClinicalTrials.gov ID
- NCT06323590
- Acronym / sponsor ID
- UAB 2372
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Mar 2024 (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 purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.
Detailed description
This will be a pilot study that will include patients with AML receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). All patients will have a planned mid-induction bone marrow assessment as standard of care. All patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. Patients with complete remission (CR) will proceed to consolidation chemotherapy as determined by the treating investigator. Patients with refractory disease will proceed to further therapy as determined by the treating investigator. All patients will be followed for long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Patients with AML, receiving standard induction chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML.
Key inclusion criteria (7 listed)
- Adult male or female, age ≥18
- Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
- Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
- Cardiac function: Ejection fraction >50-55%
- Adequate organ function for receipt for induction chemotherapy
Key exclusion criteria (7 listed)
- Any other active malignancy requiring treatment or with expected survival ≤1 year.
- Recipients of prior allogeneic stem cell transplant.
- Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
- Patients with active CNS disease
- Patients with APL
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
rates of complete remission
Time frame: 28 days
rates of complete remission in consecutive patients with AML, receiving standard induction chemotherapy, without intervening on the results of the mid-induction bone marrow biopsy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Omer Jamy principal investigator
University of Alabama at Birmingham
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 University of Alabama at Birmingham 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
rates of complete remission (time frame: 28 days). 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 8 May 2026.