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
NCT ID: NCT05886049
Last Updated: 2026-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
28 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-20
Study Completion Date
2027-12-31
Brief Summary
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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.
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Detailed Description
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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 AML patients in complete response/complete response with incomplete count recovery (CR/Cri) after intensive induction therapy with 7+3 for NPM1-mutated/FLT3-ITD wild type and NPM1-mutated/FLT3-TKD wild type or MLL (KMT2A)-rearranged AML patients \>= 18-75 years old who are candidates for intensive therapy.
SECONDARY OBJECTIVES:
I. Evaluate the pharmacokinetics of SNDX-5613 with this combination regimen and characterize clinically relevant drug-drug interactions with antifungal agents.
II. To determine the number of patients with CR/CRi out of the total number of patients treated at each dose level of this regimen.
EXPLORATORY OBJECTIVES:
I. Explore potential biomarker indicators of response and resistance in AML samples.
II. To determine the measurable residual disease negative (MRD) response (CR/Cri) and its relation to CR/Cri status out of the total number of patients treated at each dose level of this regimen.
III. Determine number of patients that undergo hematopoietic stem cell transplant (HSCT) out of the total number of patients treated at each dose level of this regimen.
IV. Assess changes in OATP1B and CYP3A plasma biomarkers during treatment with SNDX-5613 with or without antifungal agents.
V. Determine duration of response.
OUTLINE: This is a phase Ib, dose-escalation study of revumenib followed by a dose-expansion study.
INDUCTION: Patients receive revumenib orally (PO) every 12 hours (Q12h) on days 2-28, daunorubicin intravenously (IV) over 15 to 30 minutes on days 1-3, and cytarabine by continuous IV infusion (CIV) on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Induction treatment continue to Consolidation treatment. Patients with persistent disease continue to Re-Induction treatment. Patients also undergo a transthoracic echocardiogram (ECHO) or multigated acquisition scan (MUGA) during screening, bone marrow aspiration and biopsy during screening and at the end of Induction, and collection of blood during screening, on days 2, 3, 15, and at the end of Induction.
RE-INDUCTION: Patients receive revumenib PO Q12h on days 2-28, daunorubicin IV over 15 to 30 minutes on days 1-2, and cytarabine CIV on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Re-Induction treatment continue to Consolidation. Patients also undergo a transthoracic ECHO or MUGA on day 1 and bone marrow aspiration and biopsy at the end of Re-Induction.
CONSOLIDATION: Patients receive revumenib PO Q12h on days 2-28 and cytarabine CIV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at the end of Consolidation, and collection of blood on days 2, 3, 15, and at the end of Consolidation.
After completion of study treatment, patients are followed for 30 days or until death, whichever occurs first.
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 AML patients in complete response/complete response with incomplete count recovery (CR/Cri) after intensive induction therapy with 7+3 for NPM1-mutated/FLT3-ITD wild type and NPM1-mutated/FLT3-TKD wild type or MLL (KMT2A)-rearranged AML patients \>= 18-75 years old who are candidates for intensive therapy.
SECONDARY OBJECTIVES:
I. Evaluate the pharmacokinetics of SNDX-5613 with this combination regimen and characterize clinically relevant drug-drug interactions with antifungal agents.
II. To determine the number of patients with CR/CRi out of the total number of patients treated at each dose level of this regimen.
EXPLORATORY OBJECTIVES:
I. Explore potential biomarker indicators of response and resistance in AML samples.
II. To determine the measurable residual disease negative (MRD) response (CR/Cri) and its relation to CR/Cri status out of the total number of patients treated at each dose level of this regimen.
III. Determine number of patients that undergo hematopoietic stem cell transplant (HSCT) out of the total number of patients treated at each dose level of this regimen.
IV. Assess changes in OATP1B and CYP3A plasma biomarkers during treatment with SNDX-5613 with or without antifungal agents.
V. Determine duration of response.
OUTLINE: This is a phase Ib, dose-escalation study of revumenib followed by a dose-expansion study.
INDUCTION: Patients receive revumenib orally (PO) every 12 hours (Q12h) on days 2-28, daunorubicin intravenously (IV) over 15 to 30 minutes on days 1-3, and cytarabine by continuous IV infusion (CIV) on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Induction treatment continue to Consolidation treatment. Patients with persistent disease continue to Re-Induction treatment. Patients also undergo a transthoracic echocardiogram (ECHO) or multigated acquisition scan (MUGA) during screening, bone marrow aspiration and biopsy during screening and at the end of Induction, and collection of blood during screening, on days 2, 3, 15, and at the end of Induction.
RE-INDUCTION: Patients receive revumenib PO Q12h on days 2-28, daunorubicin IV over 15 to 30 minutes on days 1-2, and cytarabine CIV on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Re-Induction treatment continue to Consolidation. Patients also undergo a transthoracic ECHO or MUGA on day 1 and bone marrow aspiration and biopsy at the end of Re-Induction.
CONSOLIDATION: Patients receive revumenib PO Q12h on days 2-28 and cytarabine CIV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at the end of Consolidation, and collection of blood on days 2, 3, 15, and at the end of Consolidation.
After completion of study treatment, patients are followed for 30 days or until death, whichever occurs first.
Conditions
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Acute Myeloid Leukemia With KMT2A Rearrangement
Acute Myeloid Leukemia With NPM1 Mutation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (revumenib, daunorubicin, cytarabine)
See Detailed Description.
Group Type
EXPERIMENTAL
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo collection of blood
Bone Marrow Aspiration
Intervention Type
PROCEDURE
Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy
Intervention Type
PROCEDURE
Undergo bone marrow aspiration and biopsy
Cytarabine
Intervention Type
DRUG
Given IV
Daunorubicin
Intervention Type
DRUG
Given IV
Multigated Acquisition Scan
Intervention Type
PROCEDURE
Undergo MUGA
Revumenib
Intervention Type
DRUG
Given PO
Transthoracic Echocardiography Test
Intervention Type
PROCEDURE
Undergo transthoracic ECHO
Interventions
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Biospecimen Collection
Undergo collection of blood
Intervention Type
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
Intervention Type
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
Intervention Type
PROCEDURE
Cytarabine
Given IV
Intervention Type
DRUG
Daunorubicin
Given IV
Intervention Type
DRUG
Multigated Acquisition Scan
Undergo MUGA
Intervention Type
PROCEDURE
Revumenib
Given PO
Intervention Type
DRUG
Transthoracic Echocardiography Test
Undergo transthoracic ECHO
Intervention Type
PROCEDURE
Other Intervention Names
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Biological Sample Collection
Biospecimen Collected
Specimen Collection
Biopsy of Bone Marrow
Biopsy, Bone Marrow
.beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Alexan
Ara-C
ARA-cell
Arabine
Arabinofuranosylcytosine
Arabinosylcytosine
Aracytidine
Aracytin
Aracytine
Beta-Cytosine Arabinoside
CHX-3311
Cytarabinum
Cytarbel
Cytosar
Cytosine Arabinoside
Cytosine-.beta.-arabinoside
Cytosine-beta-arabinoside
Erpalfa
Starasid
Tarabine PFS
U 19920
U-19920
Udicil
WR-28453
Daunomycin
Daunorrubicina
DNR
Leukaemomycin C
Rubidomycin
Rubomycin C
Blood Pool Scan
Equilibrium Radionuclide Angiography
Gated Blood Pool Imaging
Gated Heart Pool Scan
MUGA
MUGA Scan
Multi-Gated Acquisition Scan
Radionuclide Ventriculogram Scan
Radionuclide Ventriculography
RNV Scan
RNVG
SYMA Scanning
Synchronized Multigated Acquisition Scanning
Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613
Menin-MLL Inhibitor SNDX-5613
Menin-MLL Interaction Inhibitor SNDX-5613
SNDX 5613
SNDX-5613
SNDX5613
TRANSTHORACIC ECHOCARDIOGRAPHY
TTE
Eligibility Criteria
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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 upper limit of normal (ULN), except for patients with Gilbert's syndrome
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (ULN)
* Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 (via the Chronic Kidney Disease Epidemiology \[CKD-EPI\] glomerular filtration rate estimation)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Ejection fraction \>= 50% (or \>= 45% if no evidence of congestive heart failure \[CHF\] or other cardiac symptoms) by transthoracic echocardiogram (TTE) or multi-gated acquisition (MUGA) scan
* White blood cells (WBC) must be \< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped within 24 hours of initiation of protocol therapy. Must not have had any signs of leukostasis requiring cytoreduction
* Female patients of childbearing potential must agree to use 2 forms of contraception from screening visit until 120 days following the last dose of study treatment. Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from screening visit until 120 days until the last dose of study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment
* Patients must have previously untreated AML with no prior treatment other than hydroxyurea. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or all-trans retinoic acid (ATRA) for initially suspected acute promyelocytic leukemia (APL) (that is ruled out) is allowed
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
* 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 upper limit of normal (ULN), except for patients with Gilbert's syndrome
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (ULN)
* Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 (via the Chronic Kidney Disease Epidemiology \[CKD-EPI\] glomerular filtration rate estimation)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Ejection fraction \>= 50% (or \>= 45% if no evidence of congestive heart failure \[CHF\] or other cardiac symptoms) by transthoracic echocardiogram (TTE) or multi-gated acquisition (MUGA) scan
* White blood cells (WBC) must be \< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped within 24 hours of initiation of protocol therapy. Must not have had any signs of leukostasis requiring cytoreduction
* Female patients of childbearing potential must agree to use 2 forms of contraception from screening visit until 120 days following the last dose of study treatment. Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from screening visit until 120 days until the last dose of study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment
* Patients must have previously untreated AML with no prior treatment other than hydroxyurea. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or all-trans retinoic acid (ATRA) for initially suspected acute promyelocytic leukemia (APL) (that is ruled out) is allowed
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SNDX-5613, daunorubicin or cytarabine
* Patients with uncontrolled intercurrent illness that would make participation in this study unduly burdensome or unsafe for patient
* Patient must not have received known strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (with the exception of the antifungal) or sensitive/narrow therapeutic substrates of MATE1 within 7 days of enrollment. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Pregnant women are excluded from this study because SNDX-5613 is a menin-KMT2A inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SNDX-5613, breastfeeding should be discontinued if the mother is treated with SNDX-5613. These potential risks may also apply to other agents used in this study
* Isolated myeloid sarcoma (i.e., patients must have blood or marrow involvement with AML to enter the study)
* Acute promyelocytic leukemia (French-American-British \[FAB\] M3)
* Active central nervous system (CNS) involvement by AML
* Uncontrolled symptomatic disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
* Patients with Fridericia's correction formula (QTcF) \>= 450 ms at screening; patients with right, left, or partial bundle branch blocks or a pacemaker who are asymptomatic are eligible regardless of QTC if cleared by cardiology for enrollment in the trial. Any factors that increase the risk of QTc prolongation or risk of arrhythmic event such as congenital long QT syndrome or family history of long QT syndrome
* Patients who will exceed a lifetime anthracycline exposure of \> 550 mg/m\^2 daunorubicin or equivalent (or \> 400 mg/m\^2 daunorubicin or equivalent in the event of prior mediastinal radiation) if they receive the maximum potential exposure to anthracyclines per protocol (including both induction and reinduction cycles)
* Patients with any gastrointestinal issue of the upper gastrointestinal (GI) tract that might affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis, etc)
* Patients who have cirrhosis with a Child-Pugh score of B or C
* Patients with Down Syndrome due to higher rates of chemotherapy-associated toxicities, and may have different pharmacokinetics, as well. Toxicities that occur at higher frequencies include cardiotoxicity, a known risk of SNDX-5613 treatment (i.e., QTcF prolongation)
* Patients with myelodysplastic syndromes (MDS) treated with previous intensive induction regimens similar to 7+3
* Patients with uncontrolled intercurrent illness that would make participation in this study unduly burdensome or unsafe for patient
* Patient must not have received known strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (with the exception of the antifungal) or sensitive/narrow therapeutic substrates of MATE1 within 7 days of enrollment. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Pregnant women are excluded from this study because SNDX-5613 is a menin-KMT2A inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SNDX-5613, breastfeeding should be discontinued if the mother is treated with SNDX-5613. These potential risks may also apply to other agents used in this study
* Isolated myeloid sarcoma (i.e., patients must have blood or marrow involvement with AML to enter the study)
* Acute promyelocytic leukemia (French-American-British \[FAB\] M3)
* Active central nervous system (CNS) involvement by AML
* Uncontrolled symptomatic disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
* Patients with Fridericia's correction formula (QTcF) \>= 450 ms at screening; patients with right, left, or partial bundle branch blocks or a pacemaker who are asymptomatic are eligible regardless of QTC if cleared by cardiology for enrollment in the trial. Any factors that increase the risk of QTc prolongation or risk of arrhythmic event such as congenital long QT syndrome or family history of long QT syndrome
* Patients who will exceed a lifetime anthracycline exposure of \> 550 mg/m\^2 daunorubicin or equivalent (or \> 400 mg/m\^2 daunorubicin or equivalent in the event of prior mediastinal radiation) if they receive the maximum potential exposure to anthracyclines per protocol (including both induction and reinduction cycles)
* Patients with any gastrointestinal issue of the upper gastrointestinal (GI) tract that might affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis, etc)
* Patients who have cirrhosis with a Child-Pugh score of B or C
* Patients with Down Syndrome due to higher rates of chemotherapy-associated toxicities, and may have different pharmacokinetics, as well. Toxicities that occur at higher frequencies include cardiotoxicity, a known risk of SNDX-5613 treatment (i.e., QTcF prolongation)
* Patients with myelodysplastic syndromes (MDS) treated with previous intensive induction regimens similar to 7+3
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alice S Mims
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center LAO
Locations
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Site Status
RECRUITING
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Site Status
SUSPENDED
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Site Status
RECRUITING
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Site Status
RECRUITING
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Site Status
RECRUITING
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Site Status
RECRUITING
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Site Status
RECRUITING
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Site Status
RECRUITING
University of Kansas Clinical Research Center
Fairway, Kansas, United States
Site Status
RECRUITING
University of Kansas Cancer Center
Kansas City, Kansas, United States
Site Status
RECRUITING
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
Site Status
RECRUITING
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Site Status
RECRUITING
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Site Status
RECRUITING
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Site Status
RECRUITING
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Site Status
RECRUITING
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
RECRUITING
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Site Status
RECRUITING
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Site Status
RECRUITING
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Site Status
RECRUITING
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Site Status
RECRUITING
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Site Status
RECRUITING
Countries
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United States
Facility Contacts
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Site Public Contact
Role: primary
954-461-2180
Site Public Contact
Role: primary
305-243-2647
Site Public Contact
Role: primary
305-243-2647
Site Public Contact
Role: primary
305-243-2647
Site Public Contact
Role: primary
305-243-2647
Site Public Contact
Role: primary
800-888-8823
Site Public Contact
Role: primary
800-804-9376
Site Public Contact
Role: primary
336-713-6771
Other Identifiers
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NCI-2023-04141
Identifier Type: -
Identifier Source: org_study_id
NCI-2023-04141
Identifier Type: REGISTRY
Identifier Source: secondary_id
10596
Identifier Type: OTHER
Identifier Source: secondary_id
10596
Identifier Type: OTHER
Identifier Source: secondary_id
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RECRUITING
PHASE1
NLA101 in Adults Receiving High Dose Chemotherapy for AML
NCT03301597
TERMINATED
PHASE2
Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
NCT06484062
RECRUITING
PHASE1
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
NCT05732103
RECRUITING
PHASE1/PHASE2
A Study of BN104 in the Treatment of Acute Leukemia
NCT06052813
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
NCT00049582
TERMINATED
PHASE1
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
NCT02632721
COMPLETED
PHASE1/PHASE2
A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
NCT06229912
RECRUITING
PHASE2
A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
NCT05360160
RECRUITING
PHASE1/PHASE2
GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia
NCT00459212
COMPLETED
PHASE1
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
NCT05367401
WITHDRAWN
PHASE1/PHASE2
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
NCT01253070
COMPLETED
PHASE2
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
NCT02143414
ACTIVE_NOT_RECRUITING
PHASE2
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
NCT05748197
RECRUITING
PHASE1
A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
NCT05326516
COMPLETED
PHASE1
A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia
NCT05886491
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
NCT02583893
COMPLETED
PHASE2
Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
NCT05396859
ACTIVE_NOT_RECRUITING
PHASE1
Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations
NCT04906031
UNKNOWN
PHASE2
Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML)
NCT01397799
COMPLETED
PHASE1