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Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy

Primary Purpose

Acute Myeloid Leukemia, Elderly

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Azacitidine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Leukemia, Azacitidine, Untreated, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kansas City Veterans Affairs Medical CenterRecruiting

Outcomes

Primary Outcome Measures

overall response rates, duration of response, toxicities

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00728520

First Posted

July 31, 2008

Last Updated

August 5, 2008

Sponsor

Kansas City Veteran Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00728520

Brief Title

Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy

Official Title

A Phase II Trial With Azacitidine Single Agent in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Who Are Ineligible for Standard Induction Therapy: A Department of Veterans Affairs Multi-Site Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Kansas City Veteran Affairs Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Prior to starting treatment individuals being considered for this study will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are required: physical exam, blood tests, ECG, chest x-ray, bone marrow aspirate and biopsy to confirm the diagnosis of AML. Treatment regimen consists of Azacitidine IV/SQ on days 1-5 every 28 days. If the Azacitidine is given IV it will be given over 15-40 minutes. The treatment will be given for a minimum of 4 treatment cycles. Blood samples will be taken every week to monitor for side effects of the Azacitidine. A bone marrow aspirate will be done every 3-4 months to determine the response to the study drug or until the disease progresses. There is also a quality of life questionnaire that will be completed at the beginning of the study and every 4 weeks while on the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Elderly

Keywords

Leukemia, Azacitidine, Untreated, Elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Other Intervention Name(s)

Vidaza

Intervention Description

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

Primary Outcome Measure Information:

Title

overall response rates, duration of response, toxicities

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

During the entire duration of the study and after study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Spencer, RN, BSN

Phone

816-861-4700

Ext

57665

sarah.spencer@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Suman Kambhampati, MD

Phone

816-861-4700

suman.kambhampati@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Verma, MD

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kansas City Veterans Affairs Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64218

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah E Spencer, RN, BSN

Phone

816-861-4700

Ext

57665

sarah.spencer@va.gov

First Name & Middle Initial & Last Name & Degree

Suman Kambhampati, MD

Phone

816-861-4700

Ext

57075

suman.kambhampati@va.gov

First Name & Middle Initial & Last Name & Degree

Suman Kambhampati, MD

First Name & Middle Initial & Last Name & Degree

Peter J. Van Veldhuizen, MD

First Name & Middle Initial & Last Name & Degree

Chao H. Huang, MD

First Name & Middle Initial & Last Name & Degree

Chester Stone, MD

12. IPD Sharing Statement

Learn more about this trial

Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy

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