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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00739388
First received: August 20, 2008
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: azacytidine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Best response (complete or partial response) [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Best response status [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: is defined as the time from trial registration until death from any cause. ] [ Designated as safety issue: No ]
  • Adverse events according to NCI CTCAE v3.0 [ Time Frame: according to NCI CTCAE v3.0 ] [ Designated as safety issue: Yes ]
  • Adjusted hospitalization time [ Time Frame: is defined as the time (nights) spent in hospital as a proportion of treatment duration (days). ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: July 2008
Study Completion Date: November 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Azacitidine
  • 5-azacytidine
  • Vidaza

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00739388

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

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00739388     History of Changes
Other Study ID Numbers: SAKK 30/07, SWS-SAKK-30/07, CDR0000612029
Study First Received: August 20, 2008
Last Updated: April 9, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014