A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged Disease.
National Cancer Institute (NCI)
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and safety of revumenib (SNDX-5613) combined with 7 + 3 induction in newly diagnosed, untreated, NPM1-mutated/FLT3-ITD wild type and NPM1-mutated/FLT3-TKD wild type or MLL(KMT2A)-rearranged, acute myeloid leukemia (AML) patients \>= 18-75 years old who are candidates for intensive induction therapy. II. To determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and safety of SNDX-5613 combined with one cycle of consolidation with high dose cytarabine in newly diagnosed…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Induction therapy: Patients ages 18-75 years at time of diagnosis with NPM1-mutated/FLT3-ITD wildtype and NPM1-mutated/FLT3-TKD wildtype or MLL (KMT2A) rearranged untreated AML and who are candidates for intensive induction chemotherapy * Because no dosing or adverse event data are currently available on the use of SNDX-5613 in combination with daunorubicin and cytarabine in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Total bilirubin =\< 2 x institutional upp…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- DrugCytarabine
Given IV
- DrugDaunorubicin
Given IV
- ProcedureMultigated Acquisition Scan
Undergo MUGA
- DrugRevumenib
Given PO
Locations (22)
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida