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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cytarabine

Idarubicin

Etoposide

Fludarabine

G-CSF

Daunorubicine

About this trial

This is an interventional treatment trial for De Novo Akute Myeloid Leukemia (AML)

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

Hannover Medical School

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

NCT ID

NCT00209833

First Posted

September 13, 2005

Last Updated

November 17, 2005

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

1. Study Identification

Unique Protocol Identification Number

NCT00209833

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hannover Medical School

Collaborators

4. Oversight

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Intervention Type

Drug

Intervention Name(s)

Idarubicin

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Type

Drug

Intervention Name(s)

G-CSF

Intervention Type

Drug

Intervention Name(s)

Daunorubicine

Primary Outcome Measure Information:

Title

Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.

Title

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 Outcome Measure Information:

Title

Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.

Title

Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnold Ganser, Prof. Dr.

Organizational Affiliation

Hannover Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hannover Medical School

City

Hannover

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24335498

Citation

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.

Results Reference

derived

PubMed Identifier

22965967

Citation

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.

Results Reference

derived

PubMed Identifier

21670448

Citation

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.

Results Reference

derived

PubMed Identifier

21372155

Citation

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.

Results Reference

derived

PubMed Identifier

21242187

Citation

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.

Results Reference

derived

PubMed Identifier

20421455

Citation

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.

Results Reference

derived

Links:

URL

http://www.kompetenznetz-leukaemie.de/

Description

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

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