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To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

Primary Purpose

Myelodysplastic Syndromes

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
decitabine
azacitidine
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

  1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk [defined by International Prognostic Scoring System (IPSS) score of ≥0.5] and recognized French-American-British (FAB) classifications
  2. Male or female, 18 years of age or older with signed informed consent
  3. Adequate renal function
  4. Demonstrated normal liver function
  5. Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
  6. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the study:

  1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if > 2 weeks from study entry and if recovered from toxic effects of therapy)
  2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
  3. Pregnancy or current lactation
  4. Significant concurrent disease, illness, or psychiatric disorder
  5. Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine

Sites / Locations

  • Birmingham Hematology and Oncology Associates
  • Stanford University Cancer Center
  • Stockton Hematology Oncology
  • Florida Cancer Specialists
  • Pasco Pinellas Cancer Center
  • Gulf Coast Oncology
  • University of Chicago
  • Siouxland Haeatology - Oncology Associates
  • Center for Cancer and Blood Disorders
  • Sletten Cancer Institute
  • Cornell Medical Center
  • Carolinas Medical Center NorthEast NorthEast Oncology Associates
  • Gabrail Cancer Center
  • Oncology and Hematology Care
  • University of Pittsburgh School of Medicine
  • Charleston Hematology Oncology Associates
  • Sarah Cannon Cancer Center
  • Utah Cancer Specialists
  • Gunderson Clinic Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.

Secondary Outcome Measures

Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.

Full Information

First Posted
November 5, 2009
Last Updated
October 21, 2014
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01011283
Brief Title
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
Official Title
A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to insufficient enrollment.
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
MDS, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
decitabine
Other Intervention Name(s)
Dacogen (decitabine)
Intervention Description
decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
Intervention Type
Drug
Intervention Name(s)
azacitidine
Other Intervention Name(s)
Vidaza (azacitidine)
Intervention Description
azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Description
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
Time Frame
13 Weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Description
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
Time Frame
36 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects who meet all of the following criteria may be included in the study: Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk [defined by International Prognostic Scoring System (IPSS) score of ≥0.5] and recognized French-American-British (FAB) classifications Male or female, 18 years of age or older with signed informed consent Adequate renal function Demonstrated normal liver function Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received. Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the study: Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if > 2 weeks from study entry and if recovered from toxic effects of therapy) Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment) Pregnancy or current lactation Significant concurrent disease, illness, or psychiatric disorder Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Stein
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Stanford University Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stockton Hematology Oncology
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Facility Name
Pasco Pinellas Cancer Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Gulf Coast Oncology
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Siouxland Haeatology - Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolinas Medical Center NorthEast NorthEast Oncology Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oncology and Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Gunderson Clinic Ltd.
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

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