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Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (MACS0911)

10. marts 2016 opdateret af: Novartis Pharmaceuticals

A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Aomori, Japan, 030-8553
        • Novartis Investigative Site
      • Gifu, Japan, 501-1194
        • Novartis Investigative Site
      • Kyoto, Japan, 602-8566
        • Novartis Investigative Site
      • Saga, Japan, 849-8501
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 466-8560
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 453-8511
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Novartis Investigative Site
    • Hiroshima
      • Hiroshima-city, Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto City, Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 983-8520
        • Novartis Investigative Site
    • Nagasaki
      • Nagasaki-city, Nagasaki, Japan, 852-8501
        • Novartis Investigative Site
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Japan, 545-8586
        • Novartis Investigative Site
      • OsakaSayama, Osaka, Japan, 589-8511
        • Novartis Investigative Site
      • Suita-city, Osaka, Japan, 565-0871
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • 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:

  1. Male or female patients ≥ 18 years of age.
  2. ECOG 0, 1, or 2.
  3. Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.

  4. Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)

    Suboptimal molecular response defined as all of the following conditions:

    1. Patients who have achieved CCyR (0% Ph+ chromosomes).
    2. Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on the International Scale as detected by RQ-PCR).

    The treatment with imatinib defined as:

    Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.

  5. Patients who meet the following laboratory tests criteria:

    1. total bilirubin < 1.5 x ULN,
    2. SGOT and SGPT < 2.5 x ULN,
    3. creatinine < 1.5 x ULN,
    4. Serum amylase and lipase ≤ 1.5 x ULN,
    5. Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
    6. Serum potassium, phosphorus, magnesium and calcium ≥ LLN or correctable with supplements prior to the first dose of study drug.
  6. Written informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

  1. Prior accelerated phase or blast crisis CML.
  2. Previously documented T315I mutations.
  3. Presence of chromosomal abnormalities other than Ph+.
  4. Previous treatment with any other tyrosine kinase inhibitor except imatinib.

  5. Impaired cardiac function including any one of the following:

    1. Complete left bundle branch block
    2. Congenital long QT syndrome or family history of long QT syndrome
    3. History of or presence of significant ventricular or atrial tachyarrhythmias
    4. Clinically significant resting brachycardia (<50 bpm)
    5. QTcF > 450 msec on screening ECG
    6. Use of a ventricular-paced pacemaker
    7. Myocardial infarction during the last 12 months
    8. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina).
  6. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.

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
400 mg BID
Medicin: Nilotinib
400 mg BID
Andre navne:
  • AMN107

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.
Tidsramme: 12 months after treatment
MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
12 months after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Tidsramme: 24 months after treatment
MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
24 months after treatment
Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .
Tidsramme: month 24
MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
month 24
Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .
Tidsramme: month 24
MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
month 24

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharma K.K., Novartis Pharma K.K.

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. december 2009

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

5. januar 2010

Først indsendt, der opfyldte QC-kriterier

6. januar 2010

Først opslået (Skøn)

7. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAMN107FJP01

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 Philadelphia kromosom positiv

Kliniske forsøg med Nilotinib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Singapore

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner