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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01074047
First received: February 16, 2010
Last updated: October 11, 2013
Last verified: October 2013

February 16, 2010
October 11, 2013
June 2010
February 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01074047 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of participants with adverse events [ 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 ]
  • Relapse Free Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • 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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
February 2015
February 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
Both
65 Years and older
No
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
 
NCT01074047
AZA-AML-001
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: C L Beach, PharmD Celgene Corporation
Celgene Corporation
October 2013

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