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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01074047
First received: February 16, 2010
Last updated: August 26, 2014
Last verified: August 2014
  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:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Overall Survival is defined as the median time from randomization to death from any cause


Secondary Outcome Measures:
  • One-year overall survival rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    One Year overall survival rate is defined as the percentage of participants alive at one year time point interval following randomization

  • Event free survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Event-free survival is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after Complete Remision or incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first.

  • Overall remission rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Complete remission [CR] + morphologic complete remission with incomplete blood count recovery [CRi]) and duration of remission

  • Cytogenetic complete remission rate (CRc) [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Defined as morphologic complete remission with a reversion to a normal karyotype.

  • Number of participants with adverse events (AEs) [ Time Frame: Up to 31 months; Adverse Event (AEs) will be collected up to 28 days after last study drug dose or up to last study visit, whichever is longer ] [ Designated as safety issue: No ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology.

  • EORTC-QLQ-C-30 Quality of Life Instrument [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 is a validated quality of life measure applicable to subjects with any cancer diagnosis. It is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning. Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms

  • Healthcare resource utilization [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Hospitalizations required for Treatment Emergent Adverse Events (TEAEs) including detail on number of events, total number of days hospitalized, the rate of events and days hospitalized per person-year of exposure

  • Relapse Free Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Relapse-free survival is defined only for subjects who achieve CR or CRi and is measured as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurs first

  • Duration of Remission [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The time from the date CR or CRi is first documented until the date of documented relapse from CR/CRi


Enrollment: 488
Study Start Date: June 2010
Estimated Study Completion Date: February 2015
Primary Completion Date: January 2014 (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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 26, 2014
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
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Azacitidine
Cytarabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014