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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 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

88

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Andere Namen:
  • Vidaza
Arzneimittel: 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
Andere Namen:
  • CC-5013
  • Revlimid®
Sonstiges: 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
Experimental: 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
Arzneimittel: 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
Andere Namen:
  • CC-5013
  • Revlimid®
Sonstiges: 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
Experimental: 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
Arzneimittel: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Andere Namen:
  • Vidaza
Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Kaplan Meier Estimates for One Year Survival
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Alive at One Year
Zeitfenster: Up to 12 months
Defined as the percentage of participants who survived at one year
Up to 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Celgene

Ermittler

  • Studienleiter: Robert Gale, MD, Celgene

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. April 2012

Primärer Abschluss (Tatsächlich)

19. Mai 2015

Studienabschluss (Tatsächlich)

15. Mai 2018

Studienanmeldedaten

Zuerst eingereicht

19. Mai 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2011

Zuerst gepostet (Schätzen)

24. Mai 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juni 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Juni 2019

Zuletzt verifiziert

1. Juni 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CC-5013-AML-001

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