NCT00728520

Brief Summary

The drug that will be used in this study is called Azacitidine. Azacitidine belongs to a group of drugs which may restore normal control in cancer cells by affecting the genes and proteins in the body. Azacitidine is approved by the FDA for the treatment of Myelodysplastic Syndrome (MDS), a pre-leukemic bone marrow disease. The purpose of this study is to find out what effect the drug Azacitidine has on Acute Myeloid Leukemia (AML) in elderly patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

July 31, 2008

Last Update Submit

August 5, 2008

Conditions

Acute Myeloid LeukemiaElderly

Keywords

LeukemiaAzacitidineUntreatedElderly

Outcome Measures

Primary Outcomes (1)

  • overall response rates, duration of response, toxicities

    Starting 4 weeks after treatment, during the entire study duration, and upon study completion

Secondary Outcomes (1)

  • leukemia free survival, overall survival, quality of life, assess biomarkers and predictive markers for Azacitidine responsiveness in elderly AML patients

    During the entire duration of the study and after study completion

Interventions

AzacitidineDRUG

Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.

Also known as: Vidaza

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of AML
  • Elderly patients with denovo AML or secondary AML evolving from MDS in patient \>/= 60 who decline chemotherapy or those who are not currently candidates for induction chemotherapy
  • Stable WBC \<10 x 109 and not requiring hydroxyurea, chemotherapy or leukapheresis for \>4 weeks
  • No corticosteroids, hydroxyurea, low-dose cytarabine, interferon, ir retinoids within 1 month
  • No prior decitabine
  • No valproic acid or other histone deacetylase inhibitor for at least 2 weeks
  • No G-CSF, or GM-CSF or Erythropoetin within 1 month of study entry
  • No investigational agents within 28 days
  • ECOG performance status \</= 2 or KPS \>/= 60%
  • Life expectancy \> 2 months
  • Normal organ function = Total bilirubin \</= 1.5 x ULN, AST/ALT \</= 2.5 x ULN
  • Creatinine within normal limits or creatinine clearance \>/= 60ml/min
  • Signed informed consent

You may not qualify if:

  • Patients with t(15;17) or M3-AML
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to study entry, or who have not recovered from adverse effects of agents administered earlier
  • Patients with CNS involvement of AML
  • History of allergic reactions attributed to Azacitidine or compounds of similar chemical used in this study
  • Pregnancy
  • Other serious medical or psychiatric illness which would limit survival to \< 3 months or prevent the granting of informed consent or lead to situations that would limit compliance with study requirements
  • Known positive serology for HIV, HIV positive patients with anti-retroviral therapy are ineligible
  • Active systemic bacterial, fungal or viral infection
  • Patients with severe complications of the leukemia including but not limited to active infection, uncontrolled infection, pneumonia, hypoxia, and shock
  • Patients with advanced hepatic tumors
  • Patients with poor history of medical compliance
  • Patients with known platelet refractoriness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64218, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Amit Verma, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Spencer, RN, BSN

CONTACT

816-861-4700sarah.spencer@va.gov

Suman Kambhampati, MD

CONTACT

816-861-4700suman.kambhampati@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 6, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2012

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

US(1)