Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

NCT ID: NCT00102687

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2008-08-01

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aza-5

Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

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.

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

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.

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Maintenance Aza 5 days q 4 weeks

Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks.

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Maintenance Aza 5 days q 6 weeks

Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks.

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Interventions

azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CL Beach

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Comprehensive Blood and Cancer Center, Research Department

Bakersfield, California, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Cancer Center of Colorado Springs, The Oncology Clinic, PC

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Florida Cancer Institute

New Port Richey, Florida, United States

Cancer Centers of Florida, P.A.

Ocoee, Florida, United States

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, United States

Oncology/Hematology Associates of Central Illinois, PC

Peoria, Illinois, United States

Central Indiana Cancer Centers

Indianapolis, Indiana, United States

Hematology & Oncology Specialists LLC

Metairie, Louisiana, United States

Great Lakes Cancer Institute Breslin Cancer Center

Lansing, Michigan, United States

The Center for Cancer Care and Research

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Greater Dayton Cancer Center

Kettering, Ohio, United States

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, United States

Oncology Services of Aberdeen

Aberdeen, South Dakota, United States

Avera Cancer Institute Leukemia-Bone Marrow Transplant Center

Sioux Falls, South Dakota, United States

McLeod Cancer and Blood Center

Johnson City, Tennessee, United States

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology, P.A.

Bedford, Texas, United States

Texas Cancer Center at Medical City

Dallas, Texas, United States

Texas Oncology, PA

Fort Worth, Texas, United States

San Antonio Tumor & Blood Clinic

Fredericksburg, Texas, United States

Cancer Care Centers of South Texas - HOAST

San Antonio, Texas, United States

Virginia Oncology Associates - Lake Wright Cancer Center

Norfolk, Virginia, United States

Highline Medical Oncology

Burien, Washington, United States

Puget Sound Cancer Center

Edmonds, Washington, United States

Puget Sound Cancer Center

Seattle, Washington, United States

Cancer Care Northwest

Spokane, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 29118268 (View on PubMed)

Other Identifiers

AZA PH US 2004 CL003

Identifier Type: -

Identifier Source: org_study_id