NCT06672146Toboroz2. fázis

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

A Randomized Phase II Trial of ASTX727 and Venetoclax Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toboroz
Fázis (regiszter): 2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 93 (tervezett)
Első benyújtás: 2024. nov. 1.
Kezdés: 2025. máj. 16.
Elsődleges befejezés: 2027. márc. 31.
Fő szponzor: National Cancer Institute (NCI)
Betegségek: Akut mieloid leukémia (AML)
NCT-szám: NCT06672146

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 2. fázis
Tervezett résztvevők: 93
2025. máj. 16. és az elsődleges befejezés (2027. márc. 31.) között
138 helyszín, 2 országban
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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

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (138)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
San Juan City Hospital	San Juan	Puerto Rico	Toboroz
Centro Comprensivo de Cancer de UPR	San Juan	Puerto Rico	Toboroz
University of New Mexico Cancer Center	Albuquerque	Egyesült Államok	Toboroz
Community Hospital of Anaconda	Anaconda	Egyesült Államok	Toboroz
Duluth Clinic Ashland	Ashland	Egyesült Államok	Toboroz
Augusta University Medical Center	Augusta	Egyesült Államok	Toboroz
Memorial Sloan Kettering Basking Ridge	Basking Ridge	Egyesült Államok	Toboroz
LSU Health Baton Rouge-North Clinic	Baton Rouge	Egyesült Államok	Toboroz
Our Lady of the Lake Physician Group	Baton Rouge	Egyesült Államok	Toboroz
Our Lady of The Lake	Baton Rouge	Egyesült Államok	Toboroz
Alta Bates Summit Medical Center-Herrick Campus	Berkeley	Egyesült Államok	Fut, nem toboroz
Billings Clinic Cancer Center	Billings	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Spartanburg	Boiling Springs	Egyesült Államok	Toboroz
Saint Luke's Cancer Institute - Boise	Boise	Egyesült Államok	Toboroz
Tufts Medical Center	Boston	Egyesült Államok	Toboroz
Bozeman Health Deaconess Hospital	Bozeman	Egyesült Államok	Toboroz
Trinity Health IHA Medical Group Hematology Oncology - Brighton	Brighton	Egyesült Államok	Toboroz
Mid Coast Hospital	Brunswick	Egyesült Államok	Toboroz
MaineHealth Cancer Care and IV Therapy - Brunswick	Brunswick	Egyesült Államok	Toboroz
Roswell Park Cancer Institute	Buffalo	Egyesült Államok	Toboroz
Trinity Health IHA Medical Group Hematology Oncology - Canton	Canton	Egyesült Államok	Toboroz
Carolinas Medical Center/Levine Cancer Institute	Charlotte	Egyesült Államok	Toboroz
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital	Chelsea	Egyesült Államok	Toboroz
University of Chicago Comprehensive Cancer Center	Chicago	Egyesült Államok	Toboroz
University of Illinois	Chicago	Egyesült Államok	Toboroz
Northwestern University	Chicago	Egyesült Államok	Toboroz
Henry Ford Macomb Hospital-Clinton Township	Clinton Township	Egyesült Államok	Fut, nem toboroz
Kootenai Health - Coeur d'Alene	Coeur d'Alene	Egyesült Államok	Toboroz
Memorial Sloan Kettering Commack	Commack	Egyesült Államok	Toboroz
Mercy Hospital	Coon Rapids	Egyesült Államok	Toboroz
UChicago Medicine Northwest Indiana	Crown Point	Egyesült Államok	Toboroz
Geisinger Medical Center	Danville	Egyesült Államok	Toboroz
Essentia Health - Deer River Clinic	Deer River	Egyesült Államok	Toboroz
Northwestern Medicine Cancer Center Kishwaukee	DeKalb	Egyesült Államok	Toboroz
Henry Ford Hospital	Detroit	Egyesült Államok	Fut, nem toboroz
Essentia Health Cancer Center	Duluth	Egyesült Államok	Toboroz
Duke University Medical Center	Durham	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Easley	Easley	Egyesült Államok	Toboroz
Minnesota Oncology - Edina	Edina	Egyesült Államok	Toboroz
Fairview Southdale Hospital	Edina	Egyesült Államok	Toboroz
Swedish Cancer Institute-Edmonds	Edmonds	Egyesült Államok	Toboroz
OSF Saint Francis Hospital and Medical Group	Escanaba	Egyesült Államok	Toboroz
NorthShore University HealthSystem-Evanston Hospital	Evanston	Egyesült Államok	Toboroz
University of Kansas Clinical Research Center	Fairway	Egyesült Államok	Toboroz
Genesys Hurley Cancer Institute	Flint	Egyesült Államok	Toboroz
Cancer Hematology Centers - Flint	Flint	Egyesült Államok	Toboroz
Genesee Hematology Oncology PC	Flint	Egyesült Államok	Felfüggesztve
Saint Luke's Cancer Institute - Fruitland	Fruitland	Egyesült Államok	Toboroz
Northwestern Medicine Cancer Center Delnor	Geneva	Egyesült Államok	Toboroz
Northwestern Medicine Glenview Outpatient Center	Glenview	Egyesült Államok	Toboroz
NorthShore University HealthSystem-Glenbrook Hospital	Glenview	Egyesült Államok	Toboroz
Northwestern Medicine Grayslake Outpatient Center	Grayslake	Egyesült Államok	Toboroz
Benefis Sletten Cancer Institute	Great Falls	Egyesült Államok	Toboroz
Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Egyesült Államok	Toboroz
Saint Vincent Hospital Cancer Center at Saint Mary's	Green Bay	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Eastside	Greenville	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Butternut	Greenville	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Faris	Greenville	Egyesült Államok	Toboroz
East Carolina University	Greenville	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Greer	Greer	Egyesült Államok	Toboroz
Memorial Sloan Kettering Westchester	Harrison	Egyesült Államok	Toboroz
Essentia Health Hibbing Clinic	Hibbing	Egyesült Államok	Toboroz
NorthShore University HealthSystem-Highland Park Hospital	Highland Park	Egyesült Államok	Toboroz
Edward Hines Jr VA Hospital	Hines	Egyesült Államok	Toboroz
Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Egyesült Államok	Felfüggesztve
Swedish Cancer Institute-Issaquah	Issaquah	Egyesült Államok	Toboroz
Allegiance Health	Jackson	Egyesült Államok	Fut, nem toboroz
Logan Health Medical Center	Kalispell	Egyesült Államok	Toboroz
University of Kansas Cancer Center	Kansas City	Egyesült Államok	Toboroz
University of Tennessee - Knoxville	Knoxville	Egyesült Államok	Felfüggesztve
Gundersen Lutheran Medical Center	La Crosse	Egyesült Államok	Toboroz
Northwestern Medicine Lake Forest Hospital	Lake Forest	Egyesült Államok	Toboroz
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center	Lebanon	Egyesült Államok	Toboroz
University of Arkansas for Medical Sciences	Little Rock	Egyesült Államok	Toboroz
Cooperman Barnabas Medical Center	Livingston	Egyesült Államok	Toboroz
Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Egyesült Államok	Toboroz
Monmouth Medical Center	Long Branch	Egyesült Államok	Toboroz
The James Graham Brown Cancer Center at University of Louisville	Louisville	Egyesült Államok	Toboroz
UofL Health Medical Center Northeast	Louisville	Egyesült Államok	Toboroz
William S Middleton VA Medical Center	Madison	Egyesült Államok	Toboroz
Loyola University Medical Center	Maywood	Egyesült Államok	Toboroz
Saint Luke's Cancer Institute - Meridian	Meridian	Egyesült Államok	Toboroz
Miami Cancer Institute	Miami	Egyesült Államok	Toboroz
Memorial Sloan Kettering Monmouth	Middletown	Egyesült Államok	Toboroz
Medical College of Wisconsin	Milwaukee	Egyesült Államok	Toboroz
Abbott-Northwestern Hospital	Minneapolis	Egyesült Államok	Toboroz
Community Medical Center	Missoula	Egyesült Államok	Toboroz
Memorial Sloan Kettering Bergen	Montvale	Egyesült Államok	Toboroz
Saint Luke's Cancer Institute - Nampa	Nampa	Egyesült Államok	Toboroz
Saint Alphonsus Cancer Care Center-Nampa	Nampa	Egyesült Államok	Toboroz
Rutgers Cancer Institute of New Jersey	New Brunswick	Egyesült Államok	Toboroz
UC Comprehensive Cancer Center at Silver Cross	New Lenox	Egyesült Államok	Toboroz
Memorial Sloan-Kettering Cancer Center	New York	Egyesült Államok	Toboroz
Henry Ford Medical Center-Columbus	Novi	Egyesült Államok	Fut, nem toboroz
Saint Vincent Hospital Cancer Center at Oconto Falls	Oconto Falls	Egyesült Államok	Toboroz
University of Oklahoma Health Sciences Center	Oklahoma City	Egyesült Államok	Toboroz
Northwestern Medicine Orland Park	Orland Park	Egyesült Államok	Toboroz
University of Chicago Medicine-Orland Park	Orland Park	Egyesült Államok	Toboroz
Memorial Hospital West	Pembroke Pines	Egyesült Államok	Toboroz
Thomas Jefferson University Hospital	Philadelphia	Egyesült Államok	Toboroz
UPMC Hillman Cancer Center	Pittsburgh	Egyesült Államok	Toboroz
Trinity Health Saint Joseph Mercy Oakland Hospital	Pontiac	Egyesült Államok	Toboroz
Oregon Health and Science University	Portland	Egyesült Államok	Felfüggesztve
MaineHealth Maine Medical Center - Portland	Portland	Egyesült Államok	Toboroz
Kootenai Clinic Cancer Services - Post Falls	Post Falls	Egyesült Államok	Toboroz
Rhode Island Hospital	Providence	Egyesült Államok	Toboroz
VCU Massey Comprehensive Cancer Center	Richmond	Egyesült Államok	Toboroz
University of Rochester	Rochester	Egyesült Államok	Toboroz
Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Egyesült Államok	Toboroz
Regions Hospital	Saint Paul	Egyesült Államok	Toboroz
United Hospital	Saint Paul	Egyesült Államok	Toboroz
Huntsman Cancer Institute/University of Utah	Salt Lake City	Egyesült Államok	Toboroz
Kootenai Clinic Cancer Services - Sandpoint	Sandpoint	Egyesült Államok	Toboroz
Essentia Health Sandstone	Sandstone	Egyesült Államok	Toboroz
UCSF Medical Center-Parnassus	San Francisco	Egyesült Államok	Toboroz
Mills Health Center	San Mateo	Egyesült Államok	Fut, nem toboroz
MaineHealth Maine Medical Center- Scarborough	Scarborough	Egyesült Államok	Toboroz
Swedish Medical Center-First Hill	Seattle	Egyesült Államok	Toboroz
Prisma Health Cancer Institute - Seneca	Seneca	Egyesült Államok	Toboroz
Saint Vincent Hospital Cancer Center at Sheboygan	Sheboygan	Egyesült Államok	Toboroz
Sheboygan Physicians Group	Sheboygan	Egyesült Államok	Toboroz
MaineHealth Cancer Care and IV Therapy - South Portland	South Portland	Egyesült Államok	Toboroz
Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Egyesült Államok	Toboroz
Stony Brook University Medical Center	Stony Brook	Egyesült Államok	Toboroz
Saint Vincent Hospital Cancer Center at Sturgeon Bay	Sturgeon Bay	Egyesült Államok	Toboroz
State University of New York Upstate Medical University	Syracuse	Egyesült Államok	Toboroz
Community Medical Center	Toms River	Egyesült Államok	Toboroz
Banner University Medical Center - Tucson	Tucson	Egyesült Államok	Toboroz
University of Arizona Cancer Center-North Campus	Tucson	Egyesült Államok	Toboroz
Memorial Sloan Kettering Nassau	Uniondale	Egyesült Államok	Toboroz
Essentia Health Virginia Clinic	Virginia	Egyesült Államok	Toboroz
Northwestern Medicine Cancer Center Warrenville	Warrenville	Egyesült Államok	Toboroz
Henry Ford West Bloomfield Hospital	West Bloomfield	Egyesült Államok	Fut, nem toboroz
Marshfield Medical Center - Weston	Weston	Egyesült Államok	Toboroz
University of Kansas Hospital-Westwood Cancer Center	Westwood	Egyesült Államok	Toboroz
Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Egyesült Államok	Toboroz
Wake Forest University Health Sciences	Winston-Salem	Egyesült Államok	Toboroz
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus	Ypsilanti	Egyesült Államok	Toboroz

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