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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Celgene Corporation Identifier:
First received: February 16, 2010
Last updated: August 26, 2014
Last verified: August 2014

February 16, 2010
August 26, 2014
June 2010
January 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
Overall Survival is defined as the median time from randomization to death from any cause
Overall Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01074047 on Archive Site
  • One-year overall survival rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    One Year overall survival rate is defined as the percentage of participants alive at one year time point interval following randomization
  • Event free survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Event-free survival is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after Complete Remision or incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first.
  • Overall remission rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Complete remission [CR] + morphologic complete remission with incomplete blood count recovery [CRi]) and duration of remission
  • Cytogenetic complete remission rate (CRc) [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Defined as morphologic complete remission with a reversion to a normal karyotype.
  • Number of participants with adverse events (AEs) [ Time Frame: Up to 31 months; Adverse Event (AEs) will be collected up to 28 days after last study drug dose or up to last study visit, whichever is longer ] [ Designated as safety issue: No ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology.
  • EORTC-QLQ-C-30 Quality of Life Instrument [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 is a validated quality of life measure applicable to subjects with any cancer diagnosis. It is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning. Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms
  • Healthcare resource utilization [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Hospitalizations required for Treatment Emergent Adverse Events (TEAEs) including detail on number of events, total number of days hospitalized, the rate of events and days hospitalized per person-year of exposure
  • Relapse Free Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Relapse-free survival is defined only for subjects who achieve CR or CRi and is measured as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurs first
  • Duration of Remission [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The time from the date CR or CRi is first documented until the date of documented relapse from CR/CRi
  • One-year overall survival rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Event free survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Overall remission rate and duration of remission [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Cytogenetic complete remission rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes of QoL [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Healthcare resource utilization [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

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

Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Azacitidine

    A: Azacitidine

    75 mg/m2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

    Other Name: Vidaza
  • Drug: Conventional Care Regimen

    B: Conventional Care Regimen

    Physician pre-selects prior to randomization from one of the following:

    • Intensive chemotherapy (cytarabine 100-200 mg/m2 continuous IV infusion for 7 days + anthracycline IV x 3 days) + BSC; induction with up to 2 consolidation cycles
    • Low-dose cytarabine 20 mg subcutaneous (SC) BID daily for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
    • Best Supportive Care only; until study end
  • Experimental: Azacitidine
    Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
    Intervention: Drug: Azacitidine
  • Active Comparator: Conventional Care Regimen
    Conventional Care Regimen
    Intervention: Drug: Conventional Care Regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
February 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
65 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   China,   Czech Republic,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: C L Beach, PharmD Celgene Corporation
Celgene Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP