Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Sponsor: OHSU Knight Cancer Institute • ClinicalTrials.gov ID: NCT07228273
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This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Interventions
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Biospecimen Collection
(Procedure)
Undergo blood sample collection
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Bone Marrow Aspiration
(Procedure)
Undergo bone marrow aspiration
-
Bone Marrow Biopsy
(Procedure)
Undergo bone marrow biopsy
-
Cytarabine
(Drug)
Given IV
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Daunorubicin
(Drug)
Given IV
-
Echocardiography Test
(Procedure)
Undergo ECHO
-
Fludarabine
(Drug)
Given IV
-
Idarubicin
(Drug)
Given IV
-
Multigated Acquisition Scan
(Procedure)
Undergo MUGA scan
-
Questionnaire Administration
(Other)
Ancillary studies
-
Venetoclax
(Drug)
Given PO
-
Device FLT3 Inhibitor
(Device)
FLT3 Inhibitor, Receptor-Type Tyrosine-Protein Kinase FLT3 Protein Inhibitor. Given FLT3 inhibitor
-
Idarubicin
(Drug)
(1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-alpha-L-hexopyranoside, (7S-cis)-9-Acetyl-7-\[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy\]-7,8,9,10-tetrahydro-6,9,11-trihydroxy-5,12-naphthacenedione, 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-Demethoxydaunorubicin, 4-DMDR, 58957-92-9, IDARUBICIN, Idarubicin, idarubicin, Idarubicin. Given IV
Eligibility criteria
Conditions
Locations
- OHSU Knight Cancer Institute — Portland, Oregon, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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