Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

Key facts

Study ID

NCT01074047

Run by

Celgene

People needed

488

Starts

2010-06-01

Expected to finish

2016-07-25

Last updated by the study team

2017-08-29

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of one of the following
• Newly diagnosed de novo acute myeloid leukemia (AML)
• AML secondary to myelodysplastic syndromes (MDS)
• AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
• Bone marrow blasts >30%
• Age ≥ 65 years
• Easter Cooperative Oncology Group (ECOG) 0-2

You may not qualify if…

• Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
• Previous treatment with azacitidine, decitabine or cytarabine
• Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
• AML French American British subtype (FAB M3)
• AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
• Prior bone marrow or stem cell transplantation
• Candidate for allogeneic bone marrow or stem cell transplant
• Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
• Malignant hepatic tumors
• Uncontrolled systemic infection
• Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
• Use of any experimental drug or therapy within 28 days prior to Day 1

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia
• Western Hospital — Footscray, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• St Vincent's Hospital — Fitzroy, Australia
• Wilhelminenspital, I Medizinische Abt. — Vienna, State of Vienna, Austria
• Klinikum Wels-Grieskirchen GmbH — Wels, Upper Austria, Austria
• Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung — Salzburg, Austria
• Grand Hôpital de Charleroi — Charleroi, Hainaut, Belgium
• Cliniques Universitaires UCL de Mont-Godinne — Yvoir, Namur, Belgium
• Universitair Ziekenhuis Gent — Ghent, Oost-vlaanderen, Belgium
• Algemeen Ziekenhuis Sint-Jan — Bruges, West-vlaanderen, Belgium
• Centre Hospitalier de Jolimont-Lobbes — La Louvière, Belgium
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Cancer Care Manitoba — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Ottawa Hospital General Campus — Ottawa, Ontario, Canada
• Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Centre Hospitalier de l'Université de Montréal pavilion Notre Dame — Montreal, Quebec, Canada
• Hopital du Sacre Coeur de Montréal — Montreal, Quebec, Canada
• Tom Baker Cancer Centre — Calgary, Canada
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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