This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, 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. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.
Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, 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. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
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UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States, 33180
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States, 33146
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States, 33442
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States, 33136
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States, 33324
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States, 60637
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States, 28203
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 75 Years
ALL
No
National Cancer Institute (NCI),
Alice S Mims, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center LAO
2027-12-31