Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

7 novembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

151

Fase

  • Fase 2

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

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:

  • 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.

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Aza-5
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Droga: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Sperimentale: 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.
Droga: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Sperimentale: 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.
Droga: azacitidine

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline Hemoglobin Values
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Celgene

Investigatori

  • Direttore dello studio: CL Beach, Celgene Corporation

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 (Effettivo)

1 gennaio 2005

Completamento primario (Effettivo)

1 agosto 2008

Completamento dello studio (Effettivo)

1 agosto 2008

Date di iscrizione allo studio

Primo inviato

31 gennaio 2005

Primo inviato che soddisfa i criteri di controllo qualità

31 gennaio 2005

Primo Inserito (Stima)

1 febbraio 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 novembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2019

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AZA PH US 2004 CL003

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 .

Prove cliniche su azacitidine

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Myanmar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi