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 or NUP98 Alterations Disease

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05886049
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia With KMT2A Rearrangement
  • Acute Myeloid Leukemia With NPM1 Mutation
  • Secondary Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Cytarabine — DRUG
    Given IV
  • Daunorubicin — DRUG
    Given IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Revumenib — DRUG
    Given PO
  • Transthoracic Echocardiography Test — PROCEDURE
    Undergo transthoracic ECHO

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (revumenib, daunorubicin, cytarabine)
    See Detailed Description.

Primary Outcome Measure

Recommended dose for expansion (RDE) for Induction [ Time Frame: From day 1 to 42 of Induction or Re-Induction ]

Locations (22)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Kiran Naqvi (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UM Sylvester Comprehensive Cancer Center at AventuraAventuraFlorida33180
Site Public Contact
954-461-2180
Sangeetha Venugopal (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146
Site Public Contact
305-243-2647
Sangeetha Venugopal (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442
Site Public Contact
305-243-2647
Sangeetha Venugopal (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Site Public Contact
305-243-2647
Sangeetha Venugopal (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324
Site Public Contact
305-243-2647
Sangeetha Venugopal (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Site Public Contact
[email protected]
773-702-8222
Olatoyosi M. Odenike (PRINCIPAL_INVESTIGATOR)
University of Kansas Clinical Research CenterFairwayKansas66205
Site Public Contact
[email protected]
913-588-3671
Jesus Gonzalez Lugo (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterKansas CityKansas66160
Site Public Contact
[email protected]
913-588-3671
Jesus Gonzalez Lugo (PRINCIPAL_INVESTIGATOR)
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211
Site Public Contact
[email protected]
913-588-3671
Jesus Gonzalez Lugo (PRINCIPAL_INVESTIGATOR)
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205
Site Public Contact
[email protected]
913-588-3671
Jesus Gonzalez Lugo (PRINCIPAL_INVESTIGATOR)
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201
Site Public Contact
800-888-8823
Vu H. Duong (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Site Public Contact
[email protected]
877-668-0683
Joshua F. Zeidner (PRINCIPAL_INVESTIGATOR)
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203
Site Public Contact
800-804-9376
Brittany K. Ragon (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Site Public Contact
336-713-6771
Matthew J. Wieduwilt (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219
Site Public Contact
[email protected]
513-584-7698
Emily K. Curran (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
Alice S. Mims (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-West ChesterWest ChesterOhio45069
Site Public Contact
[email protected]
513-584-7698
Emily K. Curran (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Mohamad Khawandanah (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Site Public Contact
[email protected]
888-424-2100
Paul J. Shami (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Orange, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUM Sylvester Comprehensive Cancer Center at Aventura· Aventura, FLUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Deerfield Beach· Deerfield Beach, FLUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FL

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