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Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

2019年11月7日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

151

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Aza-5
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
薬：azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
実験的：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.
薬：azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
実験的：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.
薬：azacitidine

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

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

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Baseline Hemoglobin Values
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Celgene

捜査官

  • スタディディレクター：CL Beach、Celgene Corporation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2005年1月1日

一次修了 (実際)

2008年8月1日

研究の完了 (実際)

2008年8月1日

試験登録日

最初に提出

2005年1月31日

QC基準を満たした最初の提出物

2005年1月31日

最初の投稿 (見積もり)

2005年2月1日

学習記録の更新

投稿された最後の更新 (実際)

2019年11月22日

QC基準を満たした最後の更新が送信されました

2019年11月7日

最終確認日

2019年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • AZA PH US 2004 CL003

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

骨髄異形成症候群の臨床試験

  • Sidney Kimmel Cancer Center at Thomas Jefferson...
    終了しました
    2つのステップで与えられる強度レジメンを使用した骨髄移植
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    アメリカ

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