Clinical trial · Interventional
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years
AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.
NCT00180102CI-TRIAL-00002936completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Nonlymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous PBSCT | Procedure | — | UNRESOLVED |
| Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone | Drug | — | UNRESOLVED |
| early allogeneic PBSCT within induction therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- overall survival
- measure
- relapse-free survival
Secondary outcomes (3)
- measure
- complete remission rate after induction therapy
- measure
- subgroup-analyses within the primary outcomes according to different risk factors
- measure
- development of explanatory proportional hazard-models
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7 * de novo or secondary myelodysplastic syndrome WHO-type RAEB-2 * age 16 to 60 years * written informed consent Exclusion Criteria: * severe comorbidities * severe, uncontrolled complications of the leukemia * prior therapy for AML/MDS * other simultaneous hematological malignancies * HIV-Infection * known allergies against study medication * pregnancy * missing written informed consent
References
Publications (8)
- DERIVEDKunadt 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 36064577
- DERIVEDKunadt D, Kramer M, Dill C, Altmann H, Wagenfuhr L, Mohr B, Thiede C, Rollig C, Schetelig J, Bornhauser M, Schaich M, Stolzel F. Lysyl oxidase expression is associated with inferior outcome and Extramedullary disease of acute myeloid leukemia. Biomark Res. 2020 Jun 12;8:20. doi: 10.1186/s40364-020-00200-9. eCollection 2020. PMID 32537166
- DERIVEDHeidrich K, Thiede C, Schafer-Eckart K, Schmitz N, Aulitzky WE, Kramer A, Rosler W, Hanel M, Einsele H, Baldus CD, Trappe RU, Stolzel F, Middeke JM, Rollig C, Taube F, Kramer M, Serve H, Berdel WE, Ehninger G, Bornhauser M, Schetelig J; Study Alliance Leukemia (SAL). Allogeneic hematopoietic cell transplantation in intermediate risk acute myeloid leukemia negative for FLT3-ITD, NPM1- or biallelic CEBPA mutations. Ann Oncol. 2017 Nov 1;28(11):2793-2798. doi: 10.1093/annonc/mdx500. PMID 28945881
- DERIVEDRollig C, Bornhauser M, Kramer M, Thiede C, Ho AD, Kramer A, Schafer-Eckart K, Wandt H, Hanel M, Einsele H, Aulitzky WE, Schmitz N, Berdel WE, Stelljes M, Muller-Tidow C, Krug U, Platzbecker U, Wermke M, Baldus CD, Krause SW, Stolzel F, von Bonin M, Schaich M, Serve H, Schetelig J, Ehninger G. Allogeneic stem-cell transplantation in patients with NPM1-mutated acute myeloid leukemia: results from a prospective donor versus no-donor analysis of patients after upfront HLA typing within the SAL-AML 2003 trial. J Clin Oncol. 2015 Feb 10;33(5):403-10. doi: 10.1200/JCO.2013.54.4973. Epub 2014 Dec 29.