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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

11 januari 2016 uppdaterad av: Novartis Pharmaceuticals

A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

128

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna, 92801
        • Pacific Cancer Medical Center, Inc.
      • Burbank, California, Förenta staterna, 91505-6866
        • Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
      • Concord, California, Förenta staterna, 94520
        • Bay Area Cancer Research Dept.ofBayAreaCancerResearch
      • Yorba Linda, California, Förenta staterna, 92886
        • St. Jude Heritage Medical Group Virginia Crosson Cancer Center
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32256
        • Sarah Cannon Research Institute SCRI
      • Miami, Florida, Förenta staterna, 33176
        • Advanced Medical Specialties
      • New Port Richey, Florida, Förenta staterna, 34652
        • Pasco Hernando Oncology
    • Georgia
      • Augusta, Georgia, Förenta staterna, 30912
        • Georgia Regents University MedCollege of GA Cancer Ctr 2
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, Förenta staterna, 60612
        • Stroger Cook County Hospital Division of Hematology & Onc
    • Indiana
      • Beach Grove, Indiana, Förenta staterna, 46107
        • Indiana Blood and Marrow Institute
    • Kansas
      • Witchita, Kansas, Förenta staterna, 67214-3728
        • Cancer Center of Kansas
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70115
        • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Henry Ford Hospital
    • Missouri
      • St. Louis, Missouri, Förenta staterna, 63110
        • St. Louis University Cancer Center
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68198
        • University of Nebraska Medical Center University of Nebraska Med Ctr
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
    • New York
      • Bronx, New York, Förenta staterna, 10467
        • Montefiore Medical Center
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester Medical Ct James P Wilmot Cancer Ctr
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University Medical Center Duke University Med Ctr
    • Oregon
      • Portland, Oregon, Förenta staterna, 97201
        • Oregon Health & Science University
    • South Carolina
      • Greenville, South Carolina, Förenta staterna, 29605
        • Cancer Centers of the Carolinas Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Förenta staterna, 37404
        • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
      • Germantown, Tennessee, Förenta staterna, 38138
        • The Jones Clinic
      • Nashville, Tennessee, Förenta staterna, 37203
        • Tennessee Oncology Sarah Cannon Research Inst.
    • Texas
      • Dallas, Texas, Förenta staterna, 75204
        • Baylor Research Institute Baylor Research Institute (17)
      • Houston, Texas, Förenta staterna, 77090
        • Millennium Oncology
      • Houston, Texas, Förenta staterna, 77024
        • Oncology Consultants Oncology Consultants, P.A.
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • University of Virginia
    • Washington
      • Everett, Washington, Förenta staterna, 98201
        • Providence Regional Cancer Partnership

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Nilotinib
Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Läkemedel: Nilotinib
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Confirmed Complete Molecular Response (CMR)
Tidsram: 4 years
CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.
4 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
Tidsram: 4 years

CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).

Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses.
4 years
Time to CMR, CCyR and MMR
Tidsram: 4 years
Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.
4 years
Duration of CMR, CCyR and MMR
Tidsram: 4 years
Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.
4 years
Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)
Tidsram: 4 years
Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.
4 years
Time to Progression of AP/BC
Tidsram: 4 years
Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.
4 years
Number of Participants With Loss of CCyR, MMR and CMR
Tidsram: 4 years
Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.
4 years
Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.
Tidsram: 4 years
CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.
4 years
Event-free Survival, Progression-free Survival and Overall Survival
Tidsram: 4 years
Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.
4 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2010

Primärt slutförande (Faktisk)

1 november 2014

Avslutad studie (Faktisk)

1 november 2014

Studieregistreringsdatum

Först inskickad

21 oktober 2010

Först inskickad som uppfyllde QC-kriterierna

21 oktober 2010

Första postat (Uppskatta)

25 oktober 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 januari 2016

Senast verifierad

1 januari 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CAMN107AUS28

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