CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)
11. januar 2016 oppdatert 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."
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
128
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Anaheim, California, Forente stater, 92801
- Pacific Cancer Medical Center, Inc.
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Burbank, California, Forente stater, 91505-6866
- Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
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Concord, California, Forente stater, 94520
- Bay Area Cancer Research Dept.ofBayAreaCancerResearch
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Yorba Linda, California, Forente stater, 92886
- St. Jude Heritage Medical Group Virginia Crosson Cancer Center
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Florida
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Jacksonville, Florida, Forente stater, 32256
- Sarah Cannon Research Institute SCRI
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Miami, Florida, Forente stater, 33176
- Advanced Medical Specialties
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New Port Richey, Florida, Forente stater, 34652
- Pasco Hernando Oncology
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Georgia
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Augusta, Georgia, Forente stater, 30912
- Georgia Regents University MedCollege of GA Cancer Ctr 2
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Illinois
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Chicago, Illinois, Forente stater, 60640
- Louis A. Weiss Memorial Hospital
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Chicago, Illinois, Forente stater, 60612
- Stroger Cook County Hospital Division of Hematology & Onc
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Indiana
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Beach Grove, Indiana, Forente stater, 46107
- Indiana Blood and Marrow Institute
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Kansas
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Witchita, Kansas, Forente stater, 67214-3728
- Cancer Center of Kansas
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Louisiana
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New Orleans, Louisiana, Forente stater, 70115
- LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- St. Louis University Cancer Center
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Nebraska
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Omaha, Nebraska, Forente stater, 68198
- University of Nebraska Medical Center University of Nebraska Med Ctr
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
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New York
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Bronx, New York, Forente stater, 10467
- Montefiore Medical Center
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Ct James P Wilmot Cancer Ctr
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center Duke University Med Ctr
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Oregon
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Portland, Oregon, Forente stater, 97201
- Oregon Health & Science University
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Cancer Centers of the Carolinas Cancer Center
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
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Germantown, Tennessee, Forente stater, 38138
- The Jones Clinic
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Nashville, Tennessee, Forente stater, 37203
- Tennessee Oncology Sarah Cannon Research Inst.
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Texas
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Dallas, Texas, Forente stater, 75204
- Baylor Research Institute Baylor Research Institute (17)
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Houston, Texas, Forente stater, 77090
- Millennium Oncology
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Houston, Texas, Forente stater, 77024
- Oncology Consultants Oncology Consultants, P.A.
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia
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Washington
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Everett, Washington, Forente stater, 98201
- Providence Regional Cancer Partnership
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Nilotinib
Participants received 300 mg twice daily (b.i.d.).
Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
|
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Confirmed Complete Molecular Response (CMR)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
Tidsramme: 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
|
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Time to CMR, CCyR and MMR
Tidsramme: 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.
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4 years
|
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Duration of CMR, CCyR and MMR
Tidsramme: 4 years
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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
|
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Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)
Tidsramme: 4 years
|
Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.
|
4 years
|
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Time to Progression of AP/BC
Tidsramme: 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.
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4 years
|
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Number of Participants With Loss of CCyR, MMR and CMR
Tidsramme: 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
|
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Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.
Tidsramme: 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
|
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Event-free Survival, Progression-free Survival and Overall Survival
Tidsramme: 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.
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4 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
21. oktober 2010
Først innsendt som oppfylte QC-kriteriene
21. oktober 2010
Først lagt ut (Anslag)
25. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAMN107AUS28
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