Status unknownNCT00209833Updated Nov 18, 2005

Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

A Phase 2/3 interventional study of Cytarabine and Idarubicin in De Novo Akute Myeloid Leukemia (AML), Secondary Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess of Blasts in Transformation, sponsored by Hannover Medical School. Status unknown at 1 site in Germany. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2005-11-18.

Sponsored by Hannover Medical School · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 200
Allocation: Randomized
Ages: 16 Years to 60 Years
Sex: All

Study summary

This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.

Read the detailed description

Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.

Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)

Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR

Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up

Conditions studied

De Novo Akute Myeloid Leukemia (AML)
Secondary Acute Myeloid Leukemia (AML)
Refractory Anemia With Excess of Blasts in Transformation

Browse trials for

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 200 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
diagnosis of secondary AML after chemo-/radiotherapy or MDS
diagnosis of RAEB-T
age between 16 and 60 years (including 60 years)
women after exclusion of pregnancy
written informed consent

Exclusion criteria

Exclusion Criteria:

patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
patients with DLCO \< 50%
patients with creatinine clearance \< 60 ml/min
patients with bilirubin > 2mg% (34.2 mmol/L)
patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
HIV positivity
patients with a t(15;17) translocation

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 200 participants

Interventions

DrugCytarabine
DrugIdarubicin
DrugEtoposide
DrugFludarabine
DrugG-CSF
DrugDaunorubicine

What researchers measure

Primary outcomes

Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.

Secondary outcomes

Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

Study locations

1 site

Hannover Medical School
Hannover, 30625, Germany

References and documents

Publications

Thol F, Bollin R, Gehlhaar M, Walter C, Dugas M, Suchanek KJ, Kirchner A, Huang L, Chaturvedi A, Wichmann M, Wiehlmann L, Shahswar R, Damm F, Gohring G, Schlegelberger B, Schlenk R, Dohner K, Dohner H, Krauter J, Ganser A, Heuser M. Mutations in the cohesin complex in acute myeloid leukemia: clinical and prognostic implications. Blood. 2014 Feb 6;123(6):914-20. doi: 10.1182/blood-2013-07-518746. Epub 2013 Dec 13. PubMed 24335498 ↗
Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10. PubMed 22965967 ↗
Thol F, Damm F, Ludeking A, Winschel C, Wagner K, Morgan M, Yun H, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Kanz L, Fiedler W, Kirchner H, Heil G, Krauter J, Ganser A, Heuser M. Incidence and prognostic influence of DNMT3A mutations in acute myeloid leukemia. J Clin Oncol. 2011 Jul 20;29(21):2889-96. doi: 10.1200/JCO.2011.35.4894. Epub 2011 Jun 13. PubMed 21670448 ↗
Damm F, Heuser M, Morgan M, Wagner K, Gorlich K, Grosshennig A, Hamwi I, Thol F, Surdziel E, Fiedler W, Lubbert M, Kanz L, Reuter C, Heil G, Delwel R, Lowenberg B, Valk PJ, Krauter J, Ganser A. Integrative prognostic risk score in acute myeloid leukemia with normal karyotype. Blood. 2011 Apr 28;117(17):4561-8. doi: 10.1182/blood-2010-08-303479. Epub 2011 Mar 3. PubMed 21372155 ↗
Wagner K, Damm F, Thol F, Gohring G, Gorlich K, Heuser M, Schafer I, Schlegelberger B, Heil G, Ganser A, Krauter J. FLT3-internal tandem duplication and age are the major prognostic factors in patients with relapsed acute myeloid leukemia with normal karyotype. Haematologica. 2011 May;96(5):681-6. doi: 10.3324/haematol.2010.034074. Epub 2011 Jan 17. PubMed 21242187 ↗
Thol F, Damm F, Wagner K, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Heit W, Kanz L, Schlimok G, Raghavachar A, Fiedler W, Kirchner H, Heil G, Heuser M, Krauter J, Ganser A. Prognostic impact of IDH2 mutations in cytogenetically normal acute myeloid leukemia. Blood. 2010 Jul 29;116(4):614-6. doi: 10.1182/blood-2010-03-272146. Epub 2010 Apr 26. PubMed 20421455 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00209833
Lead sponsor: Hannover Medical School
Collaborators: University of Ulm, Johann Wolfgang Goethe University Hospital, University Hospital Freiburg, University Hospital Augsburg, Humboldt-Universität zu Berlin, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Ghent, Medizinische Universitätsklinik Tübingen, Klinikum Hanover-Siloah Hospital, Ev. Krankenhaus Essen-Werden, Klinikum Wuppertal GmbH
First posted: Sep 21, 2005
Start date: Jan 1999
Completion: Sep 2005
Last update: Nov 18, 2005

Study contacts

Arnold Ganser, Prof. Dr.

principal investigator · Hannover Medical School

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Hannover Medical School

Start the discussion