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Clinical Trials in Mexico / NCT06672146
Recruiting Phase 2

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

NCT06672146 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2025-05-16
Last updated
2026-09-22

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyDecitabine and Cedazuridine →Enasidenib →Venetoclax →

Biospecimen Collection: Undergo blood sample collection

Bone Marrow Aspiration: Undergo bone marrow aspiration

Bone Marrow Biopsy: Undergo bone marrow biopsy

Decitabine and Cedazuridine: Given PO

Enasidenib: Given PO

Venetoclax: Given PO

Study summary

This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML.

ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. 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. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral blood, or with an AML defining genetic abnormality as described by the World Health Organization (WHO) classification of AML, excluding acute promyelocytic leukemia (APL) with PML-RARA * Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy * Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, luspatercept, immunosuppressive therapy, intrathecal chemotherapy, cytarabine (up to 1 g/m\^2 for the purpose of cytoreduction for hyperleukocytosis/trial eligibility), and/or leukapheresis, with a maximum limit of 1 month of exposure. * Note: White blood cell (WBC) must be \< 25 x 10\^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m\^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy. * Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy * Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\&P) exam completed within 14 days prior to registration * Participants must have a complete medical history and physical exam within 14 days prior to registration * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration) * Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration * Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF). * NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03 * Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications * Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted * Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH * In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants * Participants must be offered the opportunity to participate in specimen banking * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Primary outcome measure(s)

Trial sites (136)

FacilityCityRegionStatus
Banner University Medical Center - Tucson Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Active Not Recruiting
UCSF Medical Center-Parnassus San Francisco California Recruiting
Mills Health Center San Mateo California Active Not Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida Recruiting
Miami Cancer Institute Miami Florida Recruiting
Memorial Hospital West Pembroke Pines Florida Recruiting
Augusta University Medical Center Augusta Georgia Recruiting
Saint Luke's Cancer Institute - Boise Boise Idaho Recruiting
Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho Recruiting
Saint Luke's Cancer Institute - Fruitland Fruitland Idaho Recruiting
Saint Luke's Cancer Institute - Meridian Meridian Idaho Recruiting
Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho Recruiting
Saint Luke's Cancer Institute - Nampa Nampa Idaho Recruiting
Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho Recruiting
Kootenai Clinic Cancer Services - Sandpoint Sandpoint Idaho Recruiting
Northwestern University Chicago Illinois Recruiting
University of Illinois Chicago Illinois Recruiting
University of Chicago Comprehensive Cancer Center Chicago Illinois Recruiting
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois Recruiting
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois Recruiting
Northwestern Medicine Cancer Center Delnor Geneva Illinois Recruiting
NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois Recruiting
Northwestern Medicine Glenview Outpatient Center Glenview Illinois Recruiting
Northwestern Medicine Grayslake Outpatient Center Grayslake Illinois Recruiting
NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois Recruiting
Edward Hines Jr VA Hospital Hines Illinois Recruiting
Northwestern Medicine Lake Forest Hospital Lake Forest Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois Recruiting
Northwestern Medicine Orland Park Orland Park Illinois Recruiting
University of Chicago Medicine-Orland Park Orland Park Illinois Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois Recruiting
UChicago Medicine Northwest Indiana Crown Point Indiana Recruiting
University of Kansas Clinical Research Center Fairway Kansas Recruiting
University of Kansas Cancer Center Kansas City Kansas Recruiting
University of Kansas Hospital-Westwood Cancer Center Westwood Kansas Recruiting
The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky Recruiting

+ 96 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672146 on ClinicalTrials.gov ↗ ← All trials in Mexico