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

11 gennaio 2016 aggiornato da: 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."

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

128

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nilotinib
Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Droga: Nilotinib
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Confirmed Complete Molecular Response (CMR)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2010

Completamento primario (Effettivo)

1 novembre 2014

Completamento dello studio (Effettivo)

1 novembre 2014

Date di iscrizione allo studio

Primo inviato

21 ottobre 2010

Primo inviato che soddisfa i criteri di controllo qualità

21 ottobre 2010

Primo Inserito (Stima)

25 ottobre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

8 febbraio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 gennaio 2016

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAMN107AUS28

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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