Recruiting
Phase 2

Azacitidine

Sponsor:

Kansas City Veteran Affairs Medical Center

Code:

NCT00728520

Conditions

Acute Myeloid Leukemia

Elderly

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Azacitidine

Study Details

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.

Conditions

Acute Myeloid Leukemia

Elderly

Study ID

NCT00728520

Start date

Jul, 2008

Status verified date

Aug, 2008

Completion date

Jun, 2012

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Azacitidine

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

Primary outcome measure

  • overall response rates, duration of response, toxicities [ Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion ]

Central Contacts and Locations

Central contacts

Sarah Spencer, RN, BSN

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

Suman Kambhampati, MD

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

Locations

Kansas City Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64218

Contacts

Sarah E Spencer, RN, BSN

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

Suman Kambhampati, MD

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

Principal Investigator:

Suman Kambhampati, MD

More Information

Sponsor

Kansas City Veteran Affairs Medical Center

Last update posted

Aug 6, 2008

Last verified

Aug, 2008

Keywords

  • Leukemia
  • Azacitidine
  • Untreated
  • Elderly

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Veteran Affairs Medical Center on 2008-08-06.