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Acute Myeloid LeukemiaPhase 2AML-AZANCT00915252

Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 2 study testing azacitidine and standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 27 sites in Germany.

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

The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival). Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
azacitidine and standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
27 sitesGermany
Study dates
Jul 2009to Dec 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 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
  • Bone marrow aspirate or biopsy must contain ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
  • Age ≥ 61 years
  • Informed consent, personally signed and dated to participate in the study
  • Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.

Who cannot join

  • Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
  • Hyperleukocytosis (leukocytes > 20,000/µl) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes > 100,000/µl) according to routine practice and entered into the study when leukocyte counts below 20,000/µl are reached. This applies only for the controlled part of the study.
  • Patients with initial hyperleukocytosis above 20,000/µl can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.
  • Known central nervous system manifestation of AML
  • Cardiac Disease: Heart failure NYHA class 3 or 4; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  • Chronically impaired renal function (creatinin clearance < 30 ml / min)
Show all 19Show fewer
  • Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
  • Total bilirubin ≥ 1.5 x ULN if not caused by leukemic infiltration
  • Known HIV and/or hepatitis C infection
  • Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
  • Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
  • Uncontrolled active infection
  • Concurrent malignancies other than AML with an estimated life expectancy of less than two years
  • History of organ allograft
  • Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
  • Previous treatment of AML except hydroxyurea and up to 2 days of ≤100 mg/m2/d cytarabine
  • Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
  • Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office whether study participation is possible
  • Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites

  • RWTH Aachen, Medizinische Klinik IV

    Aachen, 52074

  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Med. Klinik V

    Bamberg, 96049

  • Klinikum Bayreuth, Medizinische Klinik IV

    Bayreuth, 95445

  • Charite Campus Benjamin Franklin, Universitätsmedizin Berlin, Medizinische Klinik III

    Berlin

  • Städt. Kliniken Bielefeld gem. GmbH, Klinikum Mitte, Klinik für Hämatologie, Onkologie, Palliativmedizin

    Bielefeld, 33604

  • Klinikum Chemnitz, Krankenhaus Küchenwald, Klinik für Innere Medizin III

    Chemnitz

  • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I

    Dresden

  • Katholische Krankenhaus Duisburg

    Duisburg, 47166

  • Universitätsklinikum Erlangen, Medizinische Klinik 5

    Erlangen

  • Universitätsklinikum Essen, Klinik für Hämatologie

    Essen

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Klinikum der Johann Wolfgang Goethe-Universität Frakfurt am Main

    Frankfurt am Main

  • Asklepios Klinik St. Georg, Hämatologische Abteilung

    Hamburg

  • St. Bernward Krankenhaus Hildesheim, Medizinische Klinik II

    Hildesheim

  • Westpfalz-Klinikum GmbH, Med. Klinik I

    Kaiserslautern, 67655

  • Stiftungsklinikum Mittelrhein, Hämatologie/ Onkologie

    Koblenz, 56068

  • Johannes Gutenberg-Universität Mainz Klinikum, III. Medizinische Klinik und Poliklinik

    Mainz

  • Phillips Universität Marburg, Fachbereich 20, ZIM

    Marburg

  • Klinikum rechts der Isar, III. Medizinische Klinik

    München

  • Universitätsklinikum Münster, Medizinische Klinik und Poliklinik A

    Münster, 48149

  • Klinikum Nürnberg, Medizinische Klinik 5

    Nuremberg

  • Klinikum Osnabrück, Klinik für Onkologie, Hämatologie, Immunologie

    Osnabrück

  • Klinikum der Universität Regensburg, Klinik und Poliklinik für Innere Medizin I

    Regensburg

  • Robert-Bosch-Krankenhaus, Zentrum für Innere Medizin

    Stuttgart

  • Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

    Trier, 2920

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, 65199

  • Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II

    Würzburg

Other trials in Germany

About this study

Official title: A Randomized, Multi-center Phase II Trial to Assess the Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Being tested
azacitidine, standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine
Keywords
Acute Myeloid Leukemia, azacitidine, elderly, demethylating agent, flt3, AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • azacitidineDrug

    Also called 5-azacytidine, Vidaza

    Starting dose has been determined during run-in dose finding part of the study. Starting dose of the interventional drug is 75 mg/m²/d. Application form:

    During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles).

    During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy.

  • standard chemotherapy (7+3 scheme): Daunorubicin, CytarabineDrug

    Also called Ara-C, Daunoblastin, DaunoXome, Alexan

    Induction therapy:

    Daunorubicin 60mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7

    Consolidation therapy:

    AraC 1g/m² twice a day on day 1,3,5

Study groups in NCT00915252
Study groupRoleWhat they receive
5-azacytidineExperimentalPatients enrolled in this arm will receive standard induction and consolidation chemotherapy preceded by 5-azacytidine. These patients will additionally receive maintenance therapy with 5-azacytidine for one year after start of induction therapy.
Receives: Drug: azacitidine
standard chemotherapyActive comparatorPatients enrolled in this arm will receive standard chemotherapy treatment.
Receives: Drug: standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine

What is being measured

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

  1. Median Event Free Survival (EFS) of all AML patients

    Measured: continously up to 12 months after start of study

Secondary outcomes (4)

  1. Median event free survival of AML patients with different cytogenetic and molecular risk groups

    Measured: continously up to 12 months after study start

  2. Median overall survival of all AML patients

    Measured: continously up to 12 month after start of study

  3. Median overall survival of AML patients with different cytogenetic and molecular risk groups

    Measured: continously up to 12 month after start of study

  4. Relapse free survival

    Measured: continously up to 12 months after start of study

Timeline

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

  1. First posted5 Jun 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012
  4. Study completionDec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00915252
Sponsor's protocol ID
101010
Acronym
AML-AZA
Status last verified
Dec 2012
First submitted
3 Jun 2009
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Krug U, Koschmieder A, Schwammbach D, Gerss J, Tidow N, Steffen B, Bug G, Brandts CH, Schaich M, Rollig C, Thiede C, Noppeney R, Stelljes M, Buchner T, Koschmieder S, Duhrsen U, Serve H, Ehninger G, Berdel WE, Muller-Tidow C. Feasibility of azacitidine added to standard chemotherapy in older patients with acute myeloid leukemia--a randomised SAL pilot study. PLoS One. 2012;7(12):e52695. doi: 10.1371/journal.pone.0052695. Epub 2012 Dec 31.

    PubMed 23300745

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azacitidine and standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 27 sites in Germany.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. 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?

Median Event Free Survival (EFS) of all AML patients (time frame: continously up to 12 months after start of study). 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 NCT00915252, 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 17 Dec 2012.

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