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Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

7. November 2019 aktualisiert von: Celgene

A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes

The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules.

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

151

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

  • Vereinigte Staaten
    • California
      • Bakersfield, California, Vereinigte Staaten, 93309
        • Comprehensive Blood and Cancer Center, Research Department
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • Tower Cancer Research Foundation
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80907
        • Cancer Center of Colorado Springs, The Oncology Clinic, PC
      • Denver, Colorado, Vereinigte Staaten, 80218
        • Rocky Mountain Cancer Centers, LLP
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • Washington Cancer Institute
    • Florida
      • New Port Richey, Florida, Vereinigte Staaten, 34652
        • Florida Cancer Institute
      • Ocoee, Florida, Vereinigte Staaten, 34761
        • Cancer Centers of Florida, P.A.
    • Illinois
      • Joliet, Illinois, Vereinigte Staaten, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Peoria, Illinois, Vereinigte Staaten, 61615-7828
        • Oncology/Hematology Associates of Central Illinois, PC
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46227
        • Central Indiana Cancer Centers
    • Louisiana
      • Metairie, Louisiana, Vereinigte Staaten, 70115
        • Hematology & Oncology Specialists LLC
    • Michigan
      • Lansing, Michigan, Vereinigte Staaten, 48910
        • Great Lakes Cancer Institute Breslin Cancer Center
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63141
        • The Center for Cancer Care and Research
    • New Jersey
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Hackensack University Medical Center
    • Ohio
      • Kettering, Ohio, Vereinigte Staaten, 45409
        • Greater Dayton Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
        • Western Pennsylvania Cancer Institute
    • South Dakota
      • Aberdeen, South Dakota, Vereinigte Staaten, 57401
        • Oncology Services of Aberdeen
      • Sioux Falls, South Dakota, Vereinigte Staaten, 57105
        • Avera Cancer Institute Leukemia-Bone Marrow Transplant Center
    • Tennessee
      • Johnson City, Tennessee, Vereinigte Staaten, 37604
        • McLeod Cancer and Blood Center
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • Bedford, Texas, Vereinigte Staaten, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Texas Cancer Center at Medical City
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • Texas Oncology, PA
      • Fredericksburg, Texas, Vereinigte Staaten, 78624
        • San Antonio Tumor & Blood Clinic
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Cancer Care Centers of South Texas - HOAST
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23502
        • Virginia Oncology Associates - Lake Wright Cancer Center
    • Washington
      • Burien, Washington, Vereinigte Staaten, 98166
        • Highline Medical Oncology
      • Edmonds, Washington, Vereinigte Staaten, 98026
        • Puget Sound Cancer Center
      • Seattle, Washington, Vereinigte Staaten, 98133
        • Puget Sound Cancer Center
      • Spokane, Washington, Vereinigte Staaten, 99218
        • Cancer Care Northwest
      • Vancouver, Washington, Vereinigte Staaten, 98684
        • Northwest Cancer Specialists, P.C.

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at least one of the following: a)Anemia with hemoglobin <110g/L and requires at least 1 unit packed red blood cell transfusions every 28 days; b)Thrombocytopenia with platelet counts <100 x 10^9/L; or c)Neutropenia with absolute neutrophil count <1.5 x 10^9/L.
  • OR, Refractory anemia with excess blasts or refractory anemia with excess blast in transformation, according to the French-American-British classification system for MDS.
  • At least 18 years of age.
  • Have a life expectancy of >7 months.
  • Unlikely to proceed to bone marrow or stem cell transplantation therapy following remission.
  • Have serum bilirubin levels less than or equal to 1.5 times the upper limit of the normal (ULN) range for the laboratory.
  • Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 x ULN.
  • Have serum creatinine levels less than or equal to 1.5 x ULN.

Exclusion Criteria:

  • Secondary MDS.
  • Prior treatment with azacitidine.
  • Any prior history of Acute Myeloid Leukemia (AML).
  • Malignant or metastatic disease within the previous 12 months.
  • Uncorrected red cell folate deficiency or vitamin B12 deficiency.
  • Hepatic tumors.
  • Radiation, chemotherapy, or cytotoxic therapy for non-MDS conditions in the previous 12 months.
  • Known or suspected hypersensitivity to azacitidine or mannitol.
  • Prior transplantation or cytotoxic therapy to treat MDS. Prior use of Revlimid and Thalomid allowed after 30 day washout.
  • Serious medical illness likely to limit survival to less than or equal to 7 months.
  • Treatment with androgenic hormones during the previous 14 days
  • Active viral infection with known human immunodeficiency virus or vial hepatitis Type B or C.
  • Treatment with other investigational drugs with the previous 30 days.

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: Aza-5
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Arzneimittel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Experimental: Aza-5-2-2
Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.
Arzneimittel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Experimental: Aza-5-2-5
Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
Arzneimittel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Experimental: Maintenance Aza 5 days q 4 weeks
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.
Arzneimittel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Experimental: Maintenance Aza 5 days q 6 weeks
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.
Arzneimittel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Zeitfenster: Day 1 (randomization) to 6 months

Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).

Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)
Day 1 (randomization) to 6 months
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Zeitfenster: Day 1 (randomization) to 6 months

IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.

Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.

Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.

(continued in Population Description)
Day 1 (randomization) to 6 months
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period
Zeitfenster: Day 1 (randomization) to 6 months
Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.
Day 1 (randomization) to 6 months
Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period
Zeitfenster: 24 months
Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.
24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline Hemoglobin Values
Zeitfenster: Day 1 (randomization)
The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)
Zeitfenster: 6 months
The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.
6 months
Change From Baseline in Hemoglobin at the End of the Maintenance Study Period
Zeitfenster: 24 months
The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.
24 months
Baseline Platelet Values
Zeitfenster: Day 1 (randomization)
The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Platelets at the End of Initial Study Period (6 Months)
Zeitfenster: 6 months
The difference between platelet values at the end of the initial study period minus the platelet values at baseline.
6 months
Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)
Zeitfenster: 24 months
The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.
24 months
Baseline Absolute Neutrophil Count (ANC) Values
Zeitfenster: Day 1 (randomization)
The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)
Zeitfenster: 6 months
The difference between ANC values at the end of the initial study period minus the ANC values at baseline.
6 months
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)
Zeitfenster: 24 months
The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.
24 months
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Zeitfenster: 6 months
Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
6 months
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Zeitfenster: 6 months
Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
6 months
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Zeitfenster: 24 months
Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
24 months
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Zeitfenster: 24 months
Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
24 months
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period
Zeitfenster: 6 months
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
6 months
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period
Zeitfenster: 24 months
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
24 months

Mitarbeiter und Ermittler

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

Sponsor

Celgene

Ermittler

  • Studienleiter: CL Beach, Celgene Corporation

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)

1. Januar 2005

Primärer Abschluss (Tatsächlich)

1. August 2008

Studienabschluss (Tatsächlich)

1. August 2008

Studienanmeldedaten

Zuerst eingereicht

31. Januar 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Januar 2005

Zuerst gepostet (Schätzen)

1. Februar 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. November 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. November 2019

Zuletzt verifiziert

1. November 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AZA PH US 2004 CL003

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