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Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

7 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

151

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aza-5
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Médicament: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Expérimental: 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.
Médicament: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Expérimental: 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.
Médicament: azacitidine

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Baseline Hemoglobin Values
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Celgene

Les enquêteurs

  • Directeur d'études: CL Beach, Celgene Corporation

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2005

Achèvement primaire (Réel)

1 août 2008

Achèvement de l'étude (Réel)

1 août 2008

Dates d'inscription aux études

Première soumission

31 janvier 2005

Première soumission répondant aux critères de contrôle qualité

31 janvier 2005

Première publication (Estimation)

1 février 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AZA PH US 2004 CL003

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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