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

Celgene

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Azacitidine; Drug: Conventional Care Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074047

AZA-AML-001

Details and patient eligibility

About

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

Enrollment: 488 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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488 participants in 2 patient groups

Azacitidine

Experimental group

Description:

Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

Treatment:

Drug: Azacitidine

Conventional Care Regimen

Active Comparator group

Description:

Conventional Care Regimen

Treatment:

Drug: Conventional Care Regimen