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Résztvevőt keres itt: Puerto Rico2. fázis

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

A legfontosabb adatok

Ki végzi
National Cancer Institute (NCI)
Hol
San Juan (Puerto Rico)Mind a 2 helyszín megnézéseMég 1 másik országban, 136 helyszínen
Azonosító
Állapot
Toboroz
Fázis
2. fázis
Résztvevők
93 fő, tervezett
Kezdés
2025. máj. 16.
Várható befejezés
2027. márc. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Decitabine and Cedazuridine
  • Enasidenib
  • Venetoclax
A regiszteradat frissítve
2026. október 27.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat újonnan diagnosztizált, még nem kezelt akut myeloid leukémiában (AML) szenvedő felnőtteket keres, akiknek IDH2 génelváltozásuk van. 60 évesek vagy idősebbek, vagy legalább 18 évesek, és nem kaphatnak szokásos, citarabin alapú kemoterápiát.

Életkor
60 év vagy idősebb; vagy legalább 18 éves, ha nem kaphat citarabin alapú indukciós kezelést.
Nem
Minden nem részt vehet.
A betegség stádiuma
Újonnan diagnosztizált, kezeletlen AML: legalább 20% blasztsejt a csontvelőben és/vagy a vérben, vagy az AML-t meghatározó genetikai eltérés. A PML-RARA pozitív akut promielocitás leukémia nem vehet részt.
Korábbi kezelés
Korábban nem kapott kezelést AML, MDS vagy MPN miatt, néhány kivétellel (például hidroxiurea, all-transz retinsav, lenalidomid, leukaferézis; legfeljebb 1 hónapig). A fehérvérsejtszámnak a kezelés kezdete előtt 25 x 10^9/L alatt kell lennie.
Biomarker vagy leletérték
Kimutatható IDH2 mutáció, amelyet a MYELOMATCH törzsprotokoll központi vizsgálata talál meg. Előbb a MYELOMATCH-be kell regisztrálni.

A részvétel fő kizáró okai

  • Más vizsgálati szert kap vagy tervez kapni a vizsgálat alatt
  • Korrigált QT-idő 480 msec vagy több (QTcF)
  • A New York Heart Association szerinti 2. osztálynál rosszabb szívműködés
  • Terhes vagy szoptat
  • Nem tudja lenyelni a szájon át szedett gyógyszereket, vagy a felszívódást zavaró emésztőrendszeri betegsége van

A regiszter feltételei, szó szerint

Mind a 22 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Helyszínek itt: Puerto Rico

Még 1 másik országban, 136 helyszínen

  • Centro Comprensivo de Cancer de UPRSan Juan, Puerto RicoContact: Luis J. Santos Reyes (principal investigator)Résztvevőt keres
  • San Juan City HospitalSan Juan, Puerto RicoContact: Luis J. Santos Reyes (principal investigator)Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Arm 1 (ASTX727 + venetoclax)Már használt kezelés, összehasonlításként

    Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

    Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine és Venetoclax

  • Arm 2 (ASTX727 + venetoclax + enasidenib)A vizsgált kezelés

    Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

    Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, Enasidenib és Venetoclax

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. október 27.