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

Purpose

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

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Azacitidine Drug: Conventional Care Regimen	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine Azacitidine

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Overall Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

One-year overall survival rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Event free survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Overall remission rate and duration of remission [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Cytogenetic complete remission rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Patient reported outcomes of QoL [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Healthcare resource utilization [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Relapse Free Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	June 2010
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Azacitidine Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity	Drug: Azacitidine A: Azacitidine 75 mg/m2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity Other Name: Vidaza
Active Comparator: Conventional Care Regimen Conventional Care Regimen	Drug: Conventional Care Regimen B: Conventional Care Regimen Physician pre-selects prior to randomization from one of the following: Intensive chemotherapy (cytarabine 100-200 mg/m2 continuous IV infusion for 7 days + anthracycline IV x 3 days) + BSC; induction with up to 2 consolidation cycles Low-dose cytarabine 20 mg subcutaneous (SC) BID daily for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity Best Supportive Care only; until study end

Arms

Assigned Interventions

Experimental: Azacitidine

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

Drug: Azacitidine

A: Azacitidine

75 mg/m2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

Other Name: Vidaza

Active Comparator: Conventional Care Regimen

Conventional Care Regimen

Drug: Conventional Care Regimen

B: Conventional Care Regimen

Physician pre-selects prior to randomization from one of the following:

Intensive chemotherapy (cytarabine 100-200 mg/m2 continuous IV infusion for 7 days + anthracycline IV x 3 days) + BSC; induction with up to 2 consolidation cycles
Low-dose cytarabine 20 mg subcutaneous (SC) BID daily for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
Best Supportive Care only; until study end

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074047

Show 112 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

C L Beach, PharmD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01074047 History of Changes
Other Study ID Numbers:	AZA-AML-001
Study First Received:	February 16, 2010
Last Updated:	November 2, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Canada: Ethics Review Committee Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Institutional Review Board Australia: Human Research Ethics Committee Austria: Ethikkommission Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Israel: Ethics Commission Israel: Ministry of Health Italy: Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Ethics Committee Poland: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Spanish Agency of Medicines Taiwan: Department of Health Taiwan: Institutional Review Board United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee China: Food and Drug Administration

Keywords provided by Celgene Corporation:

Acute Myeloid Leukemia
Cytarabine
Vidaza
azacitidine

Intensive Chemotherapy
Low Dose Cytarabine
Celgene

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013