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Acute Myeloid LeukemiaPhase 3NCT00151255

All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 3 study testing Cytarabine, Idarubicin and All-trans retinoic acid in people with Acute Myeloid Leukemia, run by University of Ulm at 29 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML). 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?
Cytarabine, Idarubicin and All-trans retinoic acid
Type of treatment
Injection or infusion
How many people
500 participants
Where
29 sitesin 2 countries
Study dates
Jun 2004to Jan 2011
Phase
Phase 3
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

  • Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia [APL])
  • Aged > 60 years
  • All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
  • Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Who cannot join

  • Bleeding independent of the AML
  • Acute promyelocytic leukemia
  • Uncontrolled infection
  • Participation in a concurrent clinical study
  • Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
  • Severe neurological or psychiatric disorder interfering with ability of giving informed consent
  • No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
  • Performance status WHO > 2

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

Germany25 sites

  • Department of Internal Medicine I, Central Hospital of Augsburg

    Augsburg, 86856

  • Department of General Internal Medicine, University Hospital of Bonn

    Bonn, 53127

  • Medical Department I, Hospital of Bremen-Mitte

    Bremen, 28177

  • Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden

    Essen, 45239

  • Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst

    Frankfurt, 65929

  • Medical Department IV, University Hospital of Giessen

    Giessen, 35392

  • Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH

    Goch, 47574

  • Centre of Internal Medicine, University Hospital of Göttingen

    Göttingen, 37075

  • Department of Oncology and Hematology, University Hospital Eppendorf

    Hamburg, 20246

  • Medical Department II, General Hospital Altona

    Hamburg, 22763

  • Medical Department III, Hospital of Hanau

    Hanau, 63450

  • Medical Department III, Hospital of Hannover-Siloah

    Hanover, 30449

  • Department of Internal Medicine I, University Hospital of Saarland

    Homburg, 66421

  • Medical Department II, City Hospital Karlsruhe gGmbH

    Karlsruhe, 76133

  • Medical Department II, University Hospital of Kiel

    Kiel, 24116

  • Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach

    Lebach, 66822

  • Department of Hematology/Oncology, Clinical Center of Lüdenscheid

    Lüdenscheid, 58515

  • Medical Department III, Clinical Center Rechts der Isar

    München, 81675

  • Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH

    Oldenburg, 26133

  • Department of Hematology and Oncology/Caritas Hospital St. Theresa

    Saarbrücken, 66113

  • Department of Oncology, Clinical Center of Stuttgart

    Stuttgart, 70174

  • Medical Department II, Diakonie Hospital

    Stuttgart, 70176

  • I. Medical Department, Hospital of Barmerzigen Brüder

    Trier, 54292

  • Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen

    Villingen-Schwenningen, 78050

  • Medical Department I, Helios Hospital Wuppertal

    Wuppertal, 42283

Other trials in Germany

Austria4 sites

  • Department of Hematology/Oncology, University Hospital of Innsbruck

    Innsbruck, 6020

  • Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern

    Linz, 4010

  • Medical Department III, St. Johann Hospital

    Salzburg, 5020

  • Center of hematology and oncology, Hanusch Hospital

    Vienna, 1140

Other trials in Austria

About this study

Official title: Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).

Read the detailed description

First Induction Therapy:

  • Cytarabine 100 mg/m² cont. i.v. days 1-5
  • Idarubicin 12 mg/m² i.v. days 1, 3
  • ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

Second Induction Therapy:

  • Cytarabine 100 mg/m² cont. i.v. days 1-5
  • Idarubicin 12 mg/m² i.v. days 1, 3
  • ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

First Consolidation Therapy:

  • Cytarabine 1000 mg/m² bid i.v. days 1-3
  • Mitoxantrone 10 mg/m² i.v. days 2, 3
  • ATRA 15 mg/m² p.o. days 4-28

Second Consolidation Therapy

  • Etoposide 100 mg/m² i.v. days 1-5
  • Idarubicin 12 mg/m² i.v. days 1,3
  • ATRA 15 mg/m² p.o. days 4-28
Being tested
Cytarabine, Idarubicin, All-trans retinoic acid, Mitoxantrone, Etoposid
Keywords
age > 60 years
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.

  • CytarabineDrug

    100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)

  • IdarubicinDrug

    12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)

  • All-trans retinoic acidDrug

    45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)

  • MitoxantroneDrug

    10mg/m² i.v. day 2-3 (first consolidation cycle)

  • EtoposidDrug

    100mg/m² i.v. Tag 1-5 (second consolidation cycle)

What is being measured

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

  1. event-free survival

    Measured: two years

Secondary outcomes (5)

  1. kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs

    Measured: during therapy

  2. complete remission (CR) rate after induction therapy

    Measured: after second induction cycle

  3. cumulative incidence of relapse

    Measured: two years

  4. cumulative incidence of death

    Measured: two years

  5. overall survival

    Measured: two years

Timeline

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

  1. First posted8 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionJun 2009
  4. Study completionJan 2011

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00151255
Sponsor's protocol ID
AMLSG06-04
Status last verified
Apr 2017
First submitted
6 Sep 2005
Last updated
19 Apr 2017
Results posted
No

Publications

  • Tassara M, Dohner K, Brossart P, Held G, Gotze K, Horst HA, Ringhoffer M, Kohne CH, Kremers S, Raghavachar A, Wulf G, Kirchen H, Nachbaur D, Derigs HG, Wattad M, Koller E, Brugger W, Matzdorff A, Greil R, Heil G, Paschka P, Gaidzik VI, Gottlicher M, Dohner H, Schlenk RF. Valproic acid in combination with all-trans retinoic acid and intensive therapy for acute myeloid leukemia in older patients. Blood. 2014 Jun 26;123(26):4027-36. doi: 10.1182/blood-2013-12-546283. Epub 2014 May 5.

    PubMed 24797300

  • Schlenk RF, Taskesen E, van Norden Y, Krauter J, Ganser A, Bullinger L, Gaidzik VI, Paschka P, Corbacioglu A, Gohring G, Kundgen A, Held G, Gotze K, Vellenga E, Kuball J, Schanz U, Passweg J, Pabst T, Maertens J, Ossenkoppele GJ, Delwel R, Dohner H, Cornelissen JJ, Dohner K, Lowenberg B. The value of allogeneic and autologous hematopoietic stem cell transplantation in prognostically favorable acute myeloid leukemia with double mutant CEBPA. Blood. 2013 Aug 29;122(9):1576-82. doi: 10.1182/blood-2013-05-503847. Epub 2013 Jul 17.

    PubMed 23863898

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cytarabine, Idarubicin and All-trans retinoic acid in people with Acute Myeloid Leukemia, run by University of Ulm at 29 sites in 2 countries.

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 4 inclusion and 8 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

event-free survival (time frame: two years). 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 NCT00151255, which also lists 2 linked publications.

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 19 Apr 2017.

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