Back to resultsAlternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility Criteria
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.
Sites / Locations
- Comprehensive Blood and Cancer Center, Research Department
- Tower Cancer Research Foundation
- Cancer Center of Colorado Springs, The Oncology Clinic, PC
- Rocky Mountain Cancer Centers, LLP
- Washington Cancer Institute
- Florida Cancer Institute
- Cancer Centers of Florida, P.A.
- Joliet Oncology-Hematology Associates, Ltd.
- Oncology/Hematology Associates of Central Illinois, PC
- Central Indiana Cancer Centers
- Hematology & Oncology Specialists LLC
- Great Lakes Cancer Institute Breslin Cancer Center
- The Center for Cancer Care and Research
- Hackensack University Medical Center
- Greater Dayton Cancer Center
- Western Pennsylvania Cancer Institute
- Oncology Services of Aberdeen
- Avera Cancer Institute Leukemia-Bone Marrow Transplant Center
- McLeod Cancer and Blood Center
- The Sarah Cannon Research Institute
- Texas Oncology, P.A.
- Texas Cancer Center at Medical City
- Texas Oncology, PA
- San Antonio Tumor & Blood Clinic
- Cancer Care Centers of South Texas - HOAST
- Virginia Oncology Associates - Lake Wright Cancer Center
- Highline Medical Oncology
- Puget Sound Cancer Center
- Puget Sound Cancer Center
- Cancer Care Northwest
- Northwest Cancer Specialists, P.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Aza-5
Aza-5-2-2
Aza-5-2-5
Maintenance Aza 5 days q 4 weeks
Maintenance Aza 5 days q 6 weeks
Arm Description
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.
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.
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.
Outcomes
Primary Outcome Measures
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.
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)
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
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)
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period
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.
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
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.
Secondary Outcome Measures
Baseline Hemoglobin Values
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.
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)
The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.
Change From Baseline in Hemoglobin at the End of the Maintenance Study Period
The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.
Baseline Platelet Values
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.
Change From Baseline in Platelets at the End of Initial Study Period (6 Months)
The difference between platelet values at the end of the initial study period minus the platelet values at baseline.
Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)
The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.
Baseline Absolute Neutrophil Count (ANC) Values
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.
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)
The difference between ANC values at the end of the initial study period minus the ANC values at baseline.
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)
The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (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.
Platelet Transfusion Status at Baseline and End of Initial Study Period (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.
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (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.
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (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.
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period
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).
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102687
Brief Title
Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
Official Title
A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
August 1, 2008 (Actual)
Study Completion Date
August 1, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aza-5
Arm Type
Experimental
Arm Description
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Arm Title
Aza-5-2-2
Arm Type
Experimental
Arm Description
Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.
Arm Title
Aza-5-2-5
Arm Type
Experimental
Arm Description
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.
Arm Title
Maintenance Aza 5 days q 4 weeks
Arm Type
Experimental
Arm Description
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.
Arm Title
Maintenance Aza 5 days q 6 weeks
Arm Type
Experimental
Arm Description
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.
Intervention Type
Drug
Intervention Name(s)
azacitidine
Intervention Description
Azacitidine is administered subcutaneously
Total of 18 cycles on treatment or early discontinuation.
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
Day 1 (randomization) to 6 months
Title
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Description
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)
Time Frame
Day 1 (randomization) to 6 months
Title
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period
Description
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.
Time Frame
Day 1 (randomization) to 6 months
Title
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
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Baseline Hemoglobin Values
Description
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.
Time Frame
Day 1 (randomization)
Title
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)
Description
The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.
Time Frame
6 months
Title
Change From Baseline in Hemoglobin at the End of the Maintenance Study Period
Description
The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.
Time Frame
24 months
Title
Baseline Platelet Values
Description
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.
Time Frame
Day 1 (randomization)
Title
Change From Baseline in Platelets at the End of Initial Study Period (6 Months)
Description
The difference between platelet values at the end of the initial study period minus the platelet values at baseline.
Time Frame
6 months
Title
Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)
Description
The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.
Time Frame
24 months
Title
Baseline Absolute Neutrophil Count (ANC) Values
Description
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.
Time Frame
Day 1 (randomization)
Title
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)
Description
The difference between ANC values at the end of the initial study period minus the ANC values at baseline.
Time Frame
6 months
Title
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)
Description
The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.
Time Frame
24 months
Title
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Description
Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
Time Frame
6 months
Title
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Description
Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
Time Frame
6 months
Title
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Description
Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
Time Frame
24 months
Title
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Description
Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
Time Frame
24 months
Title
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period
Description
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).
Time Frame
6 months
Title
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period
Description
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).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CL Beach
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Blood and Cancer Center, Research Department
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Cancer Center of Colorado Springs, The Oncology Clinic, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cancer Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, PC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Hematology & Oncology Specialists LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Great Lakes Cancer Institute Breslin Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
The Center for Cancer Care and Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Oncology Services of Aberdeen
City
Aberdeen
State/Province
South Dakota
ZIP/Postal Code
57401
Country
United States
Facility Name
Avera Cancer Institute Leukemia-Bone Marrow Transplant Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
McLeod Cancer and Blood Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology, P.A.
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Cancer Center at Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology, PA
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
San Antonio Tumor & Blood Clinic
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
Facility Name
Cancer Care Centers of South Texas - HOAST
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Oncology Associates - Lake Wright Cancer Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Highline Medical Oncology
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Puget Sound Cancer Center
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Puget Sound Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
12. IPD Sharing Statement
Citations:
Citation
R. Lyons, et al. Rapid onset of effectiveness with three alternative azacitidine (aza) dosing regimens in patients (pts) with myelodysplastic syndromes (MDS). Haematologica 2008;93(suppl 1):Abs.0232.
Results Reference
background
Citation
Lyons R, et al. Tolerability and hematologic improvement assessed using three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. Presented at the 2007 ASCO Annual Meeting, June 1-5, 2007, Chicago, IL. Abstract No. 7083
Results Reference
background
PubMed Identifier
29118268
Citation
Komrokji R, Swern AS, Grinblatt D, Lyons RM, Tobiasson M, Silverman LR, Sayar H, Vij R, Fliss A, Tu N, Sugrue MM. Azacitidine in Lower-Risk Myelodysplastic Syndromes: A Meta-Analysis of Data from Prospective Studies. Oncologist. 2018 Feb;23(2):159-170. doi: 10.1634/theoncologist.2017-0215. Epub 2017 Nov 8.
Results Reference
background
Learn more about this trial
Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
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