Phase 3
Completed N=488
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov NCT01074047 ↗Enrolled (actual)
488
Serious AEs
75.7%
Results posted
Feb 2015
Primary outcomePrimary: Kaplan-Meier Estimates for Overall Survival — 10.4; 6.5 months — p=0.0829
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimates for Overall Survival |
10.4; 6.5 | 0.0829 |
| SECONDARY One-year Overall Survival Rate |
46.5; 34.3 | — |
| SECONDARY Event-free Survival (EFS) |
6.7; 4.8 | 0.1495 |
| SECONDARY Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi) |
9.3; 10.5 | 0.5832 |
| SECONDARY Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML) |
27.8; 25.1 | 0.5384 |
| SECONDARY Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates |
10.4; 12.3 | — |
| SECONDARY Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC. |
5; 15 | 0.0376 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
234; 36; 153; 42; 188; 0 | — |
| SECONDARY Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain |
-1.5; -1.9 | — |
| SECONDARY Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain |
8.9; 6.1 | — |
| SECONDARY Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain |
8.9; 6.1 | — |
| SECONDARY Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain |
8.9; 6.1 | — |
| SECONDARY Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain |
8.9; 6.1 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea |
12.6; 6.3 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea |
12.6; 6.3 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea |
12.6; 6.3 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea |
12.6; 6.3 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea |
12.6; 6.3 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
-13.0; -9.4 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
-13.0; -9.4 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
-13.0; -9.4 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
-13.0; -9.4 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
-13.0; -9.4 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain |
-4.4; -6.1 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain |
-4.4; -6.1 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain |
-4.4; -6.1 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain |
-4.4; -6.1 | — |
| SECONDARY HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain |
-4.4; -6.1 | — |
| SECONDARY Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations |
139; 111 | — |
| SECONDARY Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year |
7.95; 4.82 | — |
| SECONDARY HRU: Number of Participants Receiving Transfusions |
154; 134 | 0.0721 |
| SECONDARY HRU: Rate of Transfusions Per Patient Year |
34.23; 36.04 | — |
| SECONDARY Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs) |
20; 13; 13; 7; 4; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01074047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.