A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

Completed · Phase 3

Conditions studied: Myelodysplastic Syndromes

In brief

The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled. See study AZA PH GL 2003 CL 001 E for information about the extension to this study.

Key facts

Study ID

NCT00071799

Run by

Celgene

People needed

358

Starts

2003-11-01

Expected to finish

2007-07-01

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of refractory anemia with excess blasts or refractory anemia with excess blasts in transformation according to the French-American-British classification system for myelodysplastic syndromes (MDS) and a relatively high risk of acute myeloid leukemia (AML) transformation, with an International Prognostic Scoring System score of INT-2 or High.
• Be 18 years of age or older
• Have a life expectancy of at least 3 months
• Be 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 normal 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 times the upper limit of normal (unless these are considered to be related to transfusion-induced secondary hemosiderosis)
• Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal

You may not qualify if…

• Secondary myelodysplastic syndromes (MDS)
• Prior treatment with azacitidine;
• Prior history of acute myeloid leukemia (AML);
• Malignant disease diagnosed within prior 12 months;
• Metastatic disease;
• Hepatic tumors;
• Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12 months;
• Prior transplantation or cytotoxic therapy to treat MDS;
• Serious medical illness likely to limit survival to 12 months or less;
• Treatment with erythropoietin or myeloid growth factors during prior 21 days or androgenic hormones during prior 13 days;
• Active HIV, viral hepatitis type B or C;
• Treatment with investigational drugs during prior 30 days;
• Within the 28-day screening period, documented red cell folate deficiency, as evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency

Where it is running

• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Oregon Cancer Center — Portland, Oregon, United States
• Western Pennsylvania Cancer Institute — Pittsburgh, Pennsylvania, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• The Newcastle Mater Miseriecordiae Hospital — Warratah, New South Wales, Australia
• Royal Brisbane Hospital — Hersten, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Institute — East Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• The Royal Perth Hospital — Perth, Western Australia, Australia
• First Clinical Base - Clinic of Hematology, MHAT - Pleven — Pleven, Bulgaria
• MHAT "St George" Clinic of Hematology, Plovdiv — Plovdiv, Bulgaria
• III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU) — Plovdiv, Bulgaria
• National Centre of Hematology and Transfusiology, Sofia — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology — Varna, Bulgaria
• University Multiprofile Hospital for Active Treatment "Sveta Marina" — Varna, Bulgaria
• Fakultni nemocnice Brno — Jihlavska, Brno, Czechia
• University of Alabama School of Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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