Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatments azacitidine, conventional care regimen
Phase phase 3
Sponsor Celgene Corporation
Start date October 2010
End date January 2014
Trial size 488 participants
Trial identifier NCT01074047, AZA-AML-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
azacitidine Vidaza
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
(Active Comparator)
Conventional Care Regimen
conventional care regimen
Physician pre-selects prior to randomization from one of the following: Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity Best Supportive Care only; until study end

Primary Outcomes

Measure
Kaplan-Meier Estimates for Overall Survival From Any Cause
time frame: Day 1 (randomization) to 40 months

Secondary Outcomes

Measure
One-year Overall Survival Rate
time frame: From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
time frame: Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months
Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
time frame: Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months
Overall Remission Rate (CR + CRi ) as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)
time frame: Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
time frame: Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
Cytogenetic Complete Remission Rate (CRc-10) by the IRC
time frame: Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
time frame: Day 1 (randomization) up to last visit completed 22 Jan 2014; Up to 40 months
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
time frame: Baseline to Cycle 3; at approximately 3 months
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
time frame: Baseline to Cycle 5, at approximately 5 months
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
time frame: Baseline to Cycle 7, at approximately 7 months
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
time frame: Baseline to Cycle 9, at approximately 9 months
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
time frame: Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
time frame: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
time frame: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
time frame: Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations
time frame: Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
time frame: Day 1 (randomization) to 40 months
HRU: Rate of Transfusions
time frame: Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
time frame: Day 1 (randomization) to 40 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.