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

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best response (complete or partial response)

Outcome Time Frame:

within 6 months

Safety Issue:


Principal Investigator

Jakob Passweg, Prof

Investigator Role:

Study Chair

Investigator Affiliation:

Hopitaux Universitaires de Geneve


Switzerland: Swissmedic

Study ID:

SAKK 30/07



Start Date:

July 2008

Completion Date:

November 2012

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid