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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


Phase 3
65 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

31 months

Safety Issue:

No

Principal Investigator

C L Beach, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

AZA-AML-001

NCT ID:

NCT01074047

Start Date:

June 2010

Completion Date:

October 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • Cytarabine
  • Vidaza
  • azacitidine
  • Intensive Chemotherapy
  • Low Dose Cytarabine
  • Celgene
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Massachusetts General HospitalBoston, Massachusetts  02114-2617