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Utvidet tilgangsprogram for SNDX-5613

28. august 2025 oppdatert av: Syndax Pharmaceuticals

Utvidet tilgangsprogram for SNDX-5613 hos pasienter med residiverende/refraktær akutte leukemier med genetiske endringer assosiert med HOXA-overekspresjon

This expanded access program will provide an investigational treatment option in a controlled clinical setting for participants who are not otherwise eligible to participate in other Syndax-sponsored clinical studies and have no approved treatment options.

Studieoversikt

Status

Ikke lenger tilgjengelig

Forhold

Intervensjon / Behandling

Studietype

Utvidet tilgang

Utvidet tilgangstype

  • Behandling IND/Protokoll

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Alabama Center for Childhood Cancer And Blood Disorders, Children's of Alabama
    • Arizona
      • Phoenix, Arizona, Forente stater, 85016
        • Phoenix Children's Hospital
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope
      • Irvine, California, Forente stater, 92618
        • City of Hope at Orange County Lennar Foundation Cancer Center
      • Los Angeles, California, Forente stater, 90095
        • UCLA, UCLA RRMC, Drug Information Center, Department of Pharmaceutical Services Drug Supply Shipment
      • Palo Alto, California, Forente stater, 94304
        • Lucile Packard Children's Hospital-Stanford
      • San Diego, California, Forente stater, 92123
        • Rady Children's Hospital
      • San Francisco, California, Forente stater, 94158
        • University of California, San Francisco
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Center for Cancer and Blood Disorders, Colorado Children's Hospital
      • Aurora, Colorado, Forente stater, 80045
        • HCTU, Division of Hematology, University of Colorado, Anschutz Medical Center
    • Florida
      • Orlando, Florida, Forente stater, 32804
        • Advent Health Orlando
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Children's Healthcare of Atlanta
      • Atlanta, Georgia, Forente stater, 30322
        • Winship Cancer Institute at Emory University
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Lurie Children's Hospital of Chicago
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago Medical Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70118
        • Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Dana-Farber Cancer Institute, Boston Children's Cancer and Blood Disorders Center
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Children's Mercy Hospital-Kansas City
      • St Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center - Washington University
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
    • New York
      • Long Island City, New York, Forente stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Forente stater, 45267
        • Division of Hematology and Oncology, Division of Pulmonary, Critical Care and Sleep Medicine, Vontz Center for Molecular Studies
      • Columbus, Ohio, Forente stater, 43210
        • OSU Medical Center
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Doernbecher Children's Hospital, Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, Forente stater, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, Forente stater, 77030
        • Texas Children's Hospital
      • Houston, Texas, Forente stater, 77030
        • Memorial Hermann-Texas Medical Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Division of Hematology and Hematologic Malignancies, University of Utah-Huntsman Cancer Hospital
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Seattle Children's Research Institute, Seattle Childrens Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  • Male or female participant aged ≥6 months.

  • Not eligible for participation in an ongoing clinical study and have no approved treatment options.

  • Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.

  • Relapsed or refractory (R/R) acute leukemia, as defined by standardized criteria, after standard of care therapy, including but not limited to 1 or 2 cycles of intensive chemotherapy, or venetoclax combinations:

    1. R/R leukemia is defined by the presence of ≥5% blasts in the bone marrow and/or persistence or reappearance of peripheral blasts.
    2. Participants with persistent leukemia after initial therapy or recurrence of leukemia at any time after achieving a response during or after the course of treatment (including allogeneic hematopoietic stem cell transplant [HSCT]) are eligible.
    3. Participants with isolated extra-medullary disease are allowed if extramedullary disease was confirmed with biopsy.
    4. Participants previously treated on a revumenib clinical study who are entering the expanded access program for post-transplant maintenance because they are not eligible to receive revumenib on study or because the study is closed are not required to meet the R/R status.
    5. Participants who underwent HSCT and are eligible to resume treatment with revumenib will be dosed with the last revumenib tolerated dose before transplant.

  • Acute leukemia harboring a lysine (K) methyltransferase 2A gene rearrangement (KMT2Ar), nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated) or any other genetic alteration with overexpression of HOXA genes predicted to potentially respond to menin inhibitors.

    • Note: As revumenib is now approved in the United States, only participants with a KMT2Ar who are not included in the United States prescribing information indication or cannot be accurately dosed (within a 20% margin) with commercial supply and require use of oral solution will be allowed into the study.

  • Adequate liver, renal, and cardiac function.

  • Use of highly effective methods of contraception are required for females and males of childbearing potential from the time of enrollment through 120 days following the last study intervention dose.

For participants currently being treated with revumenib in a Syndax-sponsored clinical study or Syndax investigator-sponsored trial, the following criteria must be met:

  • In the opinion of the Investigator, participant demonstrated acceptable benefit from and tolerability of the study intervention.
  • Participant is considered compliant with study intervention and procedures.
  • Participant does not meet any criteria for study intervention discontinuation.
  • Investigator and participant agree to continue study intervention treatment.
  • Participant continues to experience clinical benefit.

Key Exclusion Criteria:

  • Evidence of uncontrolled infection.
  • Pregnant or nursing women.
  • Cardiac or gastrointestinal disease.
  • Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD >Grade 1 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 1 week before enrollment, with the exception of steroids.
  • History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that, in the Investigator's opinion, either may interfere with the participant's participation or results in the conclusion that it is not in the best interest of the participant to participate.
  • Participants receiving other antileukemic therapy within 14 days of start of study drug and who have not recovered from previous adverse reactions.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Syndax Pharmaceuticals

Etterforskere

  • Studieleder: Medical Director, Syndax Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Datoer for studieregistrering

Først innsendt

15. juni 2023

Først innsendt som oppfylte QC-kriteriene

15. juni 2023

Først lagt ut (Faktiske)

26. juni 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. september 2025

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. august 2025

Sist bekreftet

1. august 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SNDX-5613-0707

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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