AzTrials
AzTrials

LeukemiaPhase 2NCT00739388

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

A Phase 2 study testing azacytidine in people with Leukemia, run by Swiss Cancer Institute at 11 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
azacytidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
11 sitesSwitzerland
Study dates
Jul 2008to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Switzerland11 sites

  • Kantonspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2500

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital, Luzerne

    Luzerne, CH-6000

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hopitaux Universitaires de Geneve

    Thonex-Geneve, CH-1226

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Leukemia
Being tested
azacytidine
Keywords
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)
Medical subject headings
Leukemia, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • azacytidineDrug

    Also called Azacitidine, 5-azacytidine, Vidaza

    100 mg/m2/day s.c. on days 1-5 of a 28-day cycle

Study groups in NCT00739388
Study groupRoleWhat they receive
Arm: 5-azacytidineExperimental5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.
Receives: Drug: azacytidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best response (complete or partial response)

    Measured: within 6 months

Secondary outcomes (9)

  1. Time to response

    Measured: is defined as the time from trial registration until the date the criteria for either CR or PR are first met

  2. Response duration

    Measured: 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.

  3. Best response status

    Measured: within 6 months

  4. Time to hematological improvement (HI)

    Measured: 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.

  5. Duration of HI

    Measured: 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.

  6. Event-free survival

    Measured: is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.

  7. Overall survival

    Measured: is defined as the time from trial registration until death from any cause.

  8. Adverse events according to NCI CTCAE v3.0

    Measured: according to NCI CTCAE v3.0

  9. Adjusted hospitalization time

    Measured: is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739388
Sponsor's protocol ID
SAKK 30/07
Other IDs
SWS-SAKK-30/07, CDR0000612029
Status last verified
Apr 2013
First submitted
20 Aug 2008
Last updated
10 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • Passweg JR, Pabst T, Blum S, Bargetzi M, Li Q, Heim D, Stussi G, Gregor M, Leoncini L, Meyer-Monard S, Brauchli P, Chalandon Y; Swiss Group for Clinical Cancer Research (SAKK). Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07). Leuk Lymphoma. 2014 Jan;55(1):87-91. doi: 10.3109/10428194.2013.790540. Epub 2013 May 2.

    PubMed 23547838

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azacytidine in people with Leukemia, run by Swiss Cancer Institute at 11 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best response (complete or partial response) (time frame: within 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.

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