Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study (NCT06323590) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study
United States60 participantsStarted 2024-05-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.