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A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

17. juni 2019 opdateret af: Celgene

A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • (402) Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z1
        • (405) University of Alberta Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • (401) Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • (403) Queen Elizabeth II Health Sciences Centre - VG Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • (404) The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • (400) Princess Margaret Hospital
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • (210) University of Arizona Cancer Center
    • California
      • La Jolla, California, Forenede Stater, 92093-0960
        • (180) University of California, San Diego
      • Los Angeles, California, Forenede Stater, 90048
        • (240) Cedars-Sinai Medical Center
      • Orange, California, Forenede Stater, 92868
        • (215) Hematology Oncology Medical Group
      • Sacramento, California, Forenede Stater, 95857
        • (130) UC Davis Medical Center
      • San Luis Obispo, California, Forenede Stater, 93401
        • (200) Coastal Integrative Cancer Care
      • Stanford, California, Forenede Stater, 94305
        • (125) University of Stanford
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • (115) University of Colorado Anschultz Cancer Center
    • Florida
      • Miami Beach, Florida, Forenede Stater, 33140
        • (145) Mount Sinai Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • (140) Rush University Medical Center
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • (185) The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • (175) University Lousiville
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70072
        • (195) Tulane University Hospital Tulane Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • (235) University of Minnesota
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110-1093
        • (100) Washington University School of Medicine
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • (150) Billings Clinic
    • New York
      • New York, New York, Forenede Stater, 10029-65749
        • (165) Mount Sinai Medical Center New York
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
        • (160) The Western Pennsylvania Hospital- Cancer Institute
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • (205) Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • (120) Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • (230) Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, Forenede Stater, 75390-9179
        • (105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
      • San Antonio, Texas, Forenede Stater, 78229
        • (155) Cancer Care Centers of South Texas
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • (135) University of Wisconsin

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
  • Male or female subjects aged ≥ 65
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

  • Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
  • Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
  • Suspected or proven acute promyelocytic leukemia
  • Prior bone marrow or stem cell transplantation
  • Candidate for allogeneic bone marrow or stem cell transplantation
  • AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
  • Presence of malignant disease within the previous 12 months with exceptions

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
Medicin: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Andre navne:
  • Vidaza
Medicin: Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Andre navne:
  • CC-5013
  • Revlimid®
Andet: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Eksperimentel: Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
Medicin: Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Andre navne:
  • CC-5013
  • Revlimid®
Andet: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Eksperimentel: Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
Medicin: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Andre navne:
  • Vidaza
Andet: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kaplan Meier Estimates for One Year Survival
Tidsramme: Up to 24 months
One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation
Up to 24 months
Overall Survival
Tidsramme: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
Tidsramme: Complete Response or Morphologic Incomplete Response data not analyzed.

Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.

Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Complete Response or Morphologic Incomplete Response data not analyzed.
Duration of Remission (DoR)
Tidsramme: Duration of Remission (DoR) time frame not analyzed.
Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Duration of Remission (DoR) time frame not analyzed.
Cytogenetic Complete Remission Rate (CRc)
Tidsramme: Cytogenetic Complete Remission timeframe was not analyzed.
The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Cytogenetic Complete Remission timeframe was not analyzed.
Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
Tidsramme: Overall response rate time frame was not analyzed.
Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Overall response rate time frame was not analyzed.
Progression-Free Survival (PFS)
Tidsramme: Progression-Free survival data and time frame was not analyzed.
PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Progression-Free survival data and time frame was not analyzed.
Event-Free Survival (EFS)
Tidsramme: Event-Free survival time was not analyzed.
EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Event-Free survival time was not analyzed.
Relapse-Free Survival (RFS)
Tidsramme: Relapse-Free survival time frame was not analyzed.
RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Relapse-Free survival time frame was not analyzed.
Percentage of Participants With 30-Day Treatment-Related Mortality
Tidsramme: 30 days
30-day mortality rate was defined as death from any cause within 30 days after first dose.
30 days
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Tidsramme: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
Number of Participants With a Second Primary Malignancy
Tidsramme: From randomization of the last participant up to a minimum of 4 years following discontinuation
Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.
From randomization of the last participant up to a minimum of 4 years following discontinuation

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Alive at One Year
Tidsramme: Up to 12 months
Defined as the percentage of participants who survived at one year
Up to 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Celgene

Efterforskere

  • Studieleder: Robert Gale, MD, Celgene

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 (Faktiske)

27. april 2012

Primær færdiggørelse (Faktiske)

19. maj 2015

Studieafslutning (Faktiske)

15. maj 2018

Datoer for studieregistrering

Først indsendt

19. maj 2011

Først indsendt, der opfyldte QC-kriterier

20. maj 2011

Først opslået (Skøn)

24. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CC-5013-AML-001

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 .

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CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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