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Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients (ENESTxtnd)

3. februar 2016 opdateret af: Novartis Pharmaceuticals

Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

421

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Algeriet
      • Oran, Algeriet, 31000
        • Novartis Investigative Site
    • Bouzareah
      • Alger, Bouzareah, Algeriet, 16000
        • Novartis Investigative Site
  • Argentina
      • Buenos Aires, Argentina, C1114AAN
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1221ADC
        • Novartis Investigative Site
    • Entre Rios
      • Paraná, Entre Rios, Argentina, E3100BBJ
        • Novartis Investigative Site
  • Australien
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australien, 2605
        • Novartis Investigative Site
    • New South Wales
      • Concord NSW, New South Wales, Australien, 2139
        • Novartis Investigative Site
      • Gosford, New South Wales, Australien, 2250
        • Novartis Investigative Site
      • Kingswood, New South Wales, Australien, 2747
        • Novartis Investigative Site
      • Kogarah, New South Wales, Australien, 2217
        • Novartis Investigative Site
      • Liverpool, New South Wales, Australien, 2170
        • Novartis Investigative Site
      • St. Leonards, New South Wales, Australien, 2065
        • Novartis Investigative Site
      • Westmead, New South Wales, Australien, 2145
        • Novartis Investigative Site
    • Queensland
      • Douglas, Queensland, Australien, 4810
        • Novartis Investigative Site
      • Woolloongabba, Queensland, Australien, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Novartis Investigative Site
      • Bedford Park, South Australia, Australien, 5042
        • Novartis Investigative Site
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Novartis Investigative Site
      • Clayton, Victoria, Australien, 3168
        • Novartis Investigative Site
      • Fitzroy, Victoria, Australien, 3065
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australien, 3084
        • Novartis Investigative Site
      • Parkville, Victoria, Australien, 3050
        • Novartis Investigative Site
      • Wodonga, Victoria, Australien, 3690
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Novartis Investigative Site
      • Perth, Western Australia, Australien, 6000
        • Novartis Investigative Site
  • Brasilien
    • BA
      • Salvador, BA, Brasilien, 41253-190
        • Novartis Investigative Site
    • GO
      • Goiania, GO, Brasilien, 74605-020
        • Novartis Investigative Site
    • PR
      • Curitiba, PR, Brasilien, 81520-060
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brasilien, 90430-091
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Novartis Investigative Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Novartis Investigative Site
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Novartis Investigative Site
      • Brampton, Ontario, Canada, L6R 3J7
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8V 5C2
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 4G5
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
      • Weston, Ontario, Canada, M9N 1N8
        • Novartis Investigative Site
      • Windsor, Ontario, Canada, N8W 2X3
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Novartis Investigative Site
  • Den Russiske Føderation
      • Ekaterinburg, Den Russiske Føderation, 620137
        • Novartis Investigative Site
      • Irkutsk, Den Russiske Føderation, 664079
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 125167
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 125284
        • Novartis Investigative Site
      • Nizhnii Novgorod, Den Russiske Føderation, 603126
        • Novartis Investigative Site
      • Rostov-on-Don, Den Russiske Føderation, 344090
        • Novartis Investigative Site
      • Rostov-on-Don, Den Russiske Føderation, 344022
        • Novartis Investigative Site
      • St Petersburg, Den Russiske Føderation, 191024
        • Novartis Investigative Site
      • St-Petersburg, Den Russiske Føderation, 197022
        • Novartis Investigative Site
      • Tula, Den Russiske Føderation, 300053
        • Novartis Investigative Site
    • Russia
      • Arkhangelsk, Russia, Den Russiske Føderation, 163045
        • Novartis Investigative Site
      • Novosibirsk, Russia, Den Russiske Føderation, 630051
        • Novartis Investigative Site
      • Perm, Russia, Den Russiske Føderation, 614077
        • Novartis Investigative Site
      • Ryazan, Russia, Den Russiske Føderation, 390039
        • Novartis Investigative Site
      • St Petersburg, Russia, Den Russiske Føderation, 197341
        • Novartis Investigative Site
      • Tumen, Russia, Den Russiske Føderation, 625023
        • Novartis Investigative Site
  • Egypten
      • Alexandria, Egypten, 21131
        • Novartis Investigative Site
      • Cairo, Egypten
        • Novartis Investigative Site
      • Cairo, Egypten, 11566
        • Novartis Investigative Site
      • Mansoura, Egypten, 35516
        • Novartis Investigative Site
  • Forenede Arabiske Emirater
      • Dubai, Forenede Arabiske Emirater
        • Novartis Investigative Site
  • Indien
    • Chennai
      • Tamil Nadu, Chennai, Indien, 600035
        • Novartis Investigative Site
    • Maharashtra
      • Pune, Maharashtra, Indien, 411004
        • Novartis Investigative Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, Indien, 632004
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
  • Libanon
      • Beirut, Libanon, 166830
        • Novartis Investigative Site
      • Saida, Libanon, 652
        • Novartis Investigative Site
  • Malaysia
      • Pulau Pinang, Malaysia, 10990
        • Novartis Investigative Site
      • Selangor, Malaysia, 68000
        • Novartis Investigative Site
  • Mexico
      • San Luis Potosi, Mexico, 78416
        • Novartis Investigative Site
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • Novartis Investigative Site
  • Oman
      • Muscat, Oman, 123
        • Novartis Investigative Site
  • Saudi Arabien
      • Dammam, Saudi Arabien, 15215
        • Novartis Investigative Site
      • Jeddah, Saudi Arabien, 21423
        • Novartis Investigative Site
      • Jeddah, Saudi Arabien, 21499
        • Novartis Investigative Site
      • Riyadh, Saudi Arabien, 11211
        • Novartis Investigative Site
      • Riyadh, Saudi Arabien, 11426
        • Novartis Investigative Site
  • Sydafrika
      • Bloemfontein, Sydafrika, 9301
        • Novartis Investigative Site
      • Observatory, Sydafrika, 7925
        • Novartis Investigative Site
      • Parktown, Sydafrika, 2193
        • Novartis Investigative Site
      • Pretoria, Sydafrika, 0002
        • Novartis Investigative Site
    • Gauteng
      • Soweto, Gauteng, Sydafrika, 2013
        • Novartis Investigative Site
  • Taiwan
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative Site
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Muang, Thailand, 40002
        • Novartis Investigative Site
  • Tunesien
      • Tunis, Tunesien, 1008
        • Novartis Investigative Site
    • Tunisie
      • Sousse, Tunisie, Tunesien, 4000
        • Novartis Investigative Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria:

  • Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
  • Uncontrolled congestive heart failure or hypertension
  • Myocardial infarction or unstable angina pectoris within past 12 months
  • Known T315I mutations
  • QTcF >450 msec
  • Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nilotinib
300 mg BID
Medicin: Nilotinib
This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
Andre navne:
  • AMN107

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Percentage of Patients Achieving MMR by 12 Months
Tidsramme: 12 months
MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Molecular Response at 24 Months
Tidsramme: 24 months
Estimated median time to first MMR by Kaplan-Meier method
24 months
Duration of Major Molecular Response
Tidsramme: 3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375
3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
Complete Cytogenetic Response
Tidsramme: 6 months
Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
6 months
Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.
Tidsramme: 6,12,18 and 24 months

* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.

Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375
6,12,18 and 24 months
Overall Survival
Tidsramme: 3, 6, 9, 12, 15, 18, 21, 24 Months
OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
3, 6, 9, 12, 15, 18, 21, 24 Months
Kaplan-Meier Estimates of Progression-free Survival
Tidsramme: 3,6,9,12,15,18,21,and 24 months
PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.
3,6,9,12,15,18,21,and 24 months
Kaplan-Meier Estimates of Failure-free Survival
Tidsramme: 3,6,9,12,15,18,21,and 24 months
Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.
3,6,9,12,15,18,21,and 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2011

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

2. december 2010

Først indsendt, der opfyldte QC-kriterier

3. december 2010

Først opslået (Skøn)

6. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAMN107E2401

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 Kronisk myeloid leukæmi

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Betingelser

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Placeringer

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