De Novo Akute Myeloid Leukemia (AML)Phase 2/3NCT00209833
Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T
A Phase 2/3 study testing Cytarabine, Idarubicin and Etoposide in people with De Novo Akute Myeloid Leukemia (AML) and Secondary Acute Myeloid Leukemia (AML), run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- De Novo Akute Myeloid Leukemia (AML), Secondary Acute Myeloid Leukemia (AML), Refractory Anemia With Excess of Blasts in Transformation
- What is being tested?
- Cytarabine, Idarubicin and Etoposide
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1999to Sep 2005
- Phase
- Phase 2/3
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)
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
- De Novo Akute Myeloid Leukemia (AML), Secondary Acute Myeloid Leukemia (AML), Refractory Anemia With Excess of Blasts in Transformation
- Being tested
- Cytarabine, Idarubicin, Etoposide, Fludarabine, G-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
IdarubicinDrug
EtoposideDrug
FludarabineDrug
G-CSFDrug
DaunorubicineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 1999
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for De Novo Akute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- 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, University Hospital Tuebingen, Klinikum Hanover-Siloah Hospital, Ev. Krankenhaus Essen-Werden, Klinikum Wuppertal GmbH
- Investigators
- Arnold Ganser, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209833
- Sponsor's protocol ID
- AML 01/99 trial
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 18 Nov 2005
- Results posted
- No
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 24335498Buchner 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 22965967Thol 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 21670448Damm 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 21372155Wagner 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 21242187Thol 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