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Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

19. september 2016 opdateret af: Stichting Hemato-Oncologie voor Volwassenen Nederland

Randomised Induction and Post Induction Therapy in Older Patients (≥61 Years of Age) With Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess Blasts (RAEB, RAEB-t)

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.

PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Compare the event-free and disease-free survival of older patients with acute myeloid leukemia, refractory anemia with excess blasts (RAEB), or RAEB in transformation treated with induction therapy comprising cytarabine in combination with two different doses of daunorubicin followed by cytarabine alone with or without post-induction therapy comprising gemtuzumab ozogamicin.

Secondary

  • Compare the complete remission rate in patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Determine the probability of relapse and death during first complete remission in patients treated with post-induction gemtuzumab ozogamicin.
  • Correlate prognostic factors (e.g., CD33 positivity, multidrug resistance phenotype, or cytogenetics) with probability of complete remission and overall, event-free, and disease-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and diagnosis (acute myeloid leukemia [AML] vs myelodysplastic syndromes [MDS]) for induction therapy. Patients are stratified according to participating center, diagnosis (AML vs MDS), induction treatment arm (I vs II), and response to induction therapy (complete remission [CR] vs no CR) for post-induction therapy.

  • Induction therapy (course 1): Patients are randomized to 1 of 2 induction treatment arms.

    • Arm I: Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV over 3 hours on days 1-3.
    • Arm II: Patients receive cytarabine as in arm I and daunorubicin as in arm I but at a higher dose.

Approximately 28-35 days after the start of course 1 (or sooner if the bone marrow shows evidence of resistant disease), patients in both arms proceed to course 2 of induction therapy.

  • Induction therapy (course 2): All patients receive cytarabine IV over 6 hours twice daily on days 1-6.

After completion of course 2, patients undergo assessment of remission status. Patients who do not achieve CR are removed from the study. Patients achieving CR proceed to post-induction therapy and undergo a second randomization.

  • Post-induction therapy: Patients are randomized to 1 of 2 post-induction treatment arms.

    • Arm I: Patients receive no further chemotherapy.
    • Arm II: Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1, 29, and 57 in the absence of disease relapse or unacceptable toxicity.

After completion of study treatment, patients are followed monthly for 1 year, every 3 months for 2 years, every 4-6 months for 2 years, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 4-5 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • England
      • Basingstoke, England, Det Forenede Kongerige, RG24 9NA
        • North Hampshire Hospital
      • Canterbury, England, Det Forenede Kongerige, CT2 7NR
        • Kent and Canterbury Hospital
      • Gillingham Kent, England, Det Forenede Kongerige, ME7 5NY
        • Medway Maritime Hospital
      • Maidstone, England, Det Forenede Kongerige, ME16 9QQ
        • Maidstone Hospital
      • Truro, Cornwall, England, Det Forenede Kongerige, TR1 3LJ
        • Royal Cornwall Hospital
    • Wales
      • Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
        • University Hospital of Wales

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

61 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML)

      • M0-M2 or M4-M7 FAB subtype

        • No AML with cytogenetic abnormality t(15;17) (M3)
      • Patients with secondary AML progressing from prior myelodysplasia* or biphenotypic leukemia are eligible

    • Refractory anemia with excess blasts (RAEB) or RAEB in transformation

      • International Prognostic Scoring System score ≥ 1.5 NOTE: *Any prior hematological disease of ≥ 4 months duration
  • No chronic myelogenous leukemia in blastic crisis
  • No prior polycythemia rubra vera
  • No primary myelofibrosis

PATIENT CHARACTERISTICS:

Age

  • 61 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)*
  • Bilirubin ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Renal

  • Creatinine ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Cardiovascular

  • No myocardial infarction within the past 6 months
  • LVEF > 50% by MUGA, echocardiogram, or other methods
  • No unstable angina
  • No unstable cardiac arrhythmia
  • No severe and/or uncontrolled hypertension

Other

  • No uncontrolled diabetes
  • No severe and/or uncontrolled infection
  • No other severe and/or uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior induction therapy for AML or myelodysplastic syndromes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A low dose Dauno
Induction 45 mg Dauno
Medicin: cytarabin
Medicin: daunorubicin hydrochlorid
Eksperimentel: ARM B high dose Dauno
Induction 90 mg Dauno
Medicin: cytarabin
Medicin: daunorubicin hydrochlorid
Ingen indgriben: Arm 1 no further treatment
Eksperimentel: Arm 2 Mylotarg
Post induction treatment with Mylotarg
Medicin: gemtuzumab ozogamicin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Event-free survival after induction therapy
Disease-free survival after maintenance therapy

Sekundære resultatmål

Resultatmål
Complete remission (CR) rate after induction therapy
Overall survival after induction therapy
Toxicity after induction therapy
Toxicity after maintenance therapy
Probability of relapse and death in first CR after maintenance therapy
Overall survival after maintenance therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Efterforskere

  • Studiestol: Jonathan Kell, MRCPath, University Hospital of Wales

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2005

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

19. juli 2005

Først indsendt, der opfyldte QC-kriterier

19. juli 2005

Først opslået (Skøn)

21. juli 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000433422
  • SAKK-AML-43
  • EU-20514
  • HOVON-AML-43

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myelodysplastiske syndromer

Kliniske forsøg med cytarabin

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Sponsor / samarbejdspartnere

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