Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

April 9, 2013 updated by: Swiss Group for Clinical Cancer Research

5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the efficacy of azacitidine in patients with newly diagnosed or untreated acute myeloid leukemia who are unsuitable for induction type chemotherapy because of age or relevant comorbidities.

Secondary

  • To evaluate survival and adverse events.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Kantonspital Aarau
      • Baden, Switzerland, CH-5404
        • Kantonsspital Baden
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bellinzona, Switzerland, CH-6500
        • Oncology Institute of Southern Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Biel, Switzerland, CH-2500
        • Spitalzentrum Biel
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Luzerne, Switzerland, CH-6000
        • Kantonsspital, Luzerne
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Thonex-Geneve, Switzerland, CH-1226
        • Hopitaux Universitaires de Geneve
      • Zurich, Switzerland, CH-8091
        • Universitaetsspital Zuerich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • De novo acute myeloid leukemia (AML)
    • AML secondary to prior hematological disease or cytotoxic treatment
  • Newly diagnosed or untreated disease
  • At least 20% blasts in the blood or bone marrow or extramedullary disease

  • Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:

    • High age or frail for the biologic age
    • Relevant comorbidities
    • Unwilling to undergo intensive chemotherapy
  • No chronic myelogenous leukemia or acute promyelocytic leukemia

PATIENT CHARACTERISTICS:

  • WHO performance status 0-3
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 2.5 times ULN
  • Serum creatinine ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • No NYHA class III-IV heart failure or relevant cardiac arrhythmia
  • No active hematological/oncological disease other than AML
  • No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent

  • No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:

    • Active autoimmune disease
    • Uncontrolled diabetes
    • Active uncontrolled infection
    • HIV infection
    • Active chronic hepatitis B or C infection
  • No known allergy or hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

  • No prior treatment for AML
  • No prior azacitidine or decitabine
  • No other concurrent experimental or investigational drugs or anticancer therapy
  • More than 30 days since participation in another clinical trial
  • No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm: 5-azacytidine
5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.
Drug: azacytidine
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
Other Names:
  • Vidaza
  • Azacitidine
  • 5-azacytidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best response (complete or partial response)
Time Frame: within 6 months
within 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to response
Time Frame: is defined as the time from trial registration until the date the criteria for either CR or PR are first met
is defined as the time from trial registration until the date the criteria for either CR or PR are first met
Response duration
Time Frame: is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.
is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.
Best response status
Time Frame: within 6 months
within 6 months
Time to hematological improvement (HI)
Time Frame: is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.
is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.
Duration of HI
Time Frame: is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.
is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.
Event-free survival
Time Frame: is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.
is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.
Overall survival
Time Frame: is defined as the time from trial registration until death from any cause.
is defined as the time from trial registration until death from any cause.
Adverse events according to NCI CTCAE v3.0
Time Frame: according to NCI CTCAE v3.0
according to NCI CTCAE v3.0
Adjusted hospitalization time
Time Frame: is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).
is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Jakob Passweg, Prof, Hopitaux Universitaires de Geneve
  • Study Chair: Sabine Blum, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 30/07
  • SWS-SAKK-30/07
  • CDR0000612029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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