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

• Status: Completed
• Trial end date: 2016-07-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine; Cytarabine

Criteria

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