Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)
Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation
2 other identifiers
interventional
3,500
1 country
1
Brief Summary
The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 1999
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
December 14, 2005
CompletedFirst Posted
Study publicly available on registry
December 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 26, 2012
October 1, 2012
7.6 years
December 14, 2005
October 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission rate, Remission duration,Relapse-free survival, Overall survival, Event-free survival
12-18months
Secondary Outcomes (1)
Time and dose compliance, Realisation of SCT, Toxicity according to WHO
12-18months
Interventions
see protocol
see protocol
see protocol
see protocol
see protocol
for details see protocol
for details see protocol
Eligibility Criteria
You may qualify if:
- Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)
- Age 16 - no upper age limit
- Written informed consent
You may not qualify if:
- Severe comorbidity
- Presence of other malignancy
- Prior anti-leukemic treatment
- Pregnancy
- Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology
Münster, 48129, Germany
Related Publications (12)
Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
PMID: 36064577DERIVEDKonstandin NP, Pastore F, Herold T, Dufour A, Rothenberg-Thurley M, Hinrichsen T, Ksienzyk B, Tschuri S, Schneider S, Hoster E, Berdel WE, Woermann BJ, Sauerland MC, Braess J, Bohlander SK, Klein HG, Hiddemann W, Metzeler KH, Spiekermann K. Genetic heterogeneity of cytogenetically normal AML with mutations of CEBPA. Blood Adv. 2018 Oct 23;2(20):2724-2731. doi: 10.1182/bloodadvances.2018016840.
PMID: 30337300DERIVEDPrassek VV, Rothenberg-Thurley M, Sauerland MC, Herold T, Janke H, Ksienzyk B, Konstandin NP, Goerlich D, Krug U, Faldum A, Berdel WE, Wormann B, Braess J, Schneider S, Subklewe M, Bohlander SK, Hiddemann W, Spiekermann K, Metzeler KH. Genetics of acute myeloid leukemia in the elderly: mutation spectrum and clinical impact in intensively treated patients aged 75 years or older. Haematologica. 2018 Nov;103(11):1853-1861. doi: 10.3324/haematol.2018.191536. Epub 2018 Jun 14.
PMID: 29903761DERIVEDPastore F, Greif PA, Schneider S, Ksienzyk B, Mellert G, Zellmeier E, Braess J, Sauerland CM, Heinecke A, Krug U, Berdel WE, Buechner T, Woermann B, Hiddemann W, Spiekermann K. The NPM1 mutation type has no impact on survival in cytogenetically normal AML. PLoS One. 2014 Oct 9;9(10):e109759. doi: 10.1371/journal.pone.0109759. eCollection 2014.
PMID: 25299584DERIVEDHerold T, Metzeler KH, Vosberg S, Hartmann L, Rollig C, Stolzel F, Schneider S, Hubmann M, Zellmeier E, Ksienzyk B, Jurinovic V, Pasalic Z, Kakadia PM, Dufour A, Graf A, Krebs S, Blum H, Sauerland MC, Buchner T, Berdel WE, Woermann BJ, Bornhauser M, Ehninger G, Mansmann U, Hiddemann W, Bohlander SK, Spiekermann K, Greif PA. Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis. Blood. 2014 Aug 21;124(8):1304-11. doi: 10.1182/blood-2013-12-540716. Epub 2014 Jun 12.
PMID: 24923295DERIVEDHubmann M, Kohnke T, Hoster E, Schneider S, Dufour A, Zellmeier E, Fiegl M, Braess J, Bohlander SK, Subklewe M, Sauerland MC, Berdel WE, Buchner T, Wormann B, Hiddemann W, Spiekermann K. Molecular response assessment by quantitative real-time polymerase chain reaction after induction therapy in NPM1-mutated patients identifies those at high risk of relapse. Haematologica. 2014 Aug;99(8):1317-25. doi: 10.3324/haematol.2014.104133. Epub 2014 May 9.
PMID: 24816240DERIVEDStelljes M, Krug U, Beelen DW, Braess J, Sauerland MC, Heinecke A, Ligges S, Sauer T, Tschanter P, Thoennissen GB, Berning B, Kolb HJ, Reichle A, Holler E, Schwerdtfeger R, Arnold R, Scheid C, Muller-Tidow C, Woermann BJ, Hiddemann W, Berdel WE, Buchner T. Allogeneic transplantation versus chemotherapy as postremission therapy for acute myeloid leukemia: a prospective matched pairs analysis. J Clin Oncol. 2014 Feb 1;32(4):288-96. doi: 10.1200/JCO.2013.50.5768. Epub 2013 Dec 23.
PMID: 24366930DERIVEDOpatz S, Polzer H, Herold T, Konstandin NP, Ksienzyk B, Zellmeier E, Vosberg S, Graf A, Krebs S, Blum H, Hopfner KP, Kakadia PM, Schneider S, Dufour A, Braess J, Sauerland MC, Berdel WE, Buchner T, Woermann BJ, Hiddemann W, Spiekermann K, Bohlander SK, Greif PA. Exome sequencing identifies recurring FLT3 N676K mutations in core-binding factor leukemia. Blood. 2013 Sep 5;122(10):1761-9. doi: 10.1182/blood-2013-01-476473. Epub 2013 Jul 22.
PMID: 23878140DERIVEDBuchner 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.
PMID: 22965967DERIVEDGreif PA, Dufour A, Konstandin NP, Ksienzyk B, Zellmeier E, Tizazu B, Sturm J, Benthaus T, Herold T, Yaghmaie M, Dorge P, Hopfner KP, Hauser A, Graf A, Krebs S, Blum H, Kakadia PM, Schneider S, Hoster E, Schneider F, Stanulla M, Braess J, Sauerland MC, Berdel WE, Buchner T, Woermann BJ, Hiddemann W, Spiekermann K, Bohlander SK. GATA2 zinc finger 1 mutations associated with biallelic CEBPA mutations define a unique genetic entity of acute myeloid leukemia. Blood. 2012 Jul 12;120(2):395-403. doi: 10.1182/blood-2012-01-403220. Epub 2012 May 30.
PMID: 22649106DERIVEDStelljes M, Beelen DW, Braess J, Sauerland MC, Heinecke A, Berning B, Kolb HJ, Holler E, Schwerdtfeger R, Arnold R, Spiekermann K, Muller-Tidow C, Serve HL, Silling G, Hiddemann W, Berdel WE, Buchner T, Kienast J; German AML Cooperative Group (AMLCG). Allogeneic transplantation as post-remission therapy for cytogenetically high-risk acute myeloid leukemia: landmark analysis from a single prospective multicenter trial. Haematologica. 2011 Jul;96(7):972-9. doi: 10.3324/haematol.2011.041004. Epub 2011 Apr 1.
PMID: 21459795DERIVEDLin YH, Kakadia PM, Chen Y, Li YQ, Deshpande AJ, Buske C, Zhang KL, Zhang Y, Xu GL, Bohlander SK. Global reduction of the epigenetic H3K79 methylation mark and increased chromosomal instability in CALM-AF10-positive leukemias. Blood. 2009 Jul 16;114(3):651-8. doi: 10.1182/blood-2009-03-209395. Epub 2009 May 14.
PMID: 19443658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thomas Buechner, MD PhD
University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Thomas Büchner MD PhD, University Hospital Muenster
Study Record Dates
First Submitted
December 14, 2005
First Posted
December 15, 2005
Study Start
June 1, 1999
Primary Completion
January 1, 2007
Study Completion
October 1, 2012
Last Updated
October 26, 2012
Record last verified: 2012-10