Leukemia study questions need for immediate second chemo after bone marrow test
NCT ID NCT06323590
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether it is safe to wait before giving a second round of chemotherapy to adults newly diagnosed with acute myeloid leukemia (AML), even if a mid-treatment bone marrow biopsy shows some remaining disease. About 60 participants will receive standard first chemo, and doctors will not act on the biopsy results to start more chemo right away. The goal is to see if this approach still leads to complete remission, helping refine future treatment guidelines.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult male or female, age ≥18 2. 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. 3. 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. 4. Cardiac function: Ejection fraction \>50-55% 5. Adequate organ function for receipt for induction chemotherapy 6. Patients with HIV and Hepatitis B or C should have controlled disease. 7. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Exclusion Criteria: 1. Any other active malignancy requiring treatment or with expected survival ≤1 year. 2. Recipients of prior allogeneic stem cell transplant. 3. Patients with psychiatric illness or social situation that would limit compliance with the study requirements. 4. Patients with active CNS disease 5. Patients with APL 6. Received any investigational drugs within the 14 days prior to the first day of induction 7. Pregnant and/or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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