Clinical trial · Observational
Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia
Assessment of Novel Molecular Markers in Acute Myeloid Leukemia
NCT00900224CI-TRIAL-00069230unknownClinicalTrials.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)
RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tissue and blood samples from 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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Previously procured and archived bone marrow aspirate samples, blood and buccal cell samples, and bone marrow biopsy slides are analyzed for FLT3 ITD, MLL PTD, NPM1, KIT, KRAS, NRAS, CEBPA, WT1, JAK2, RUNX1, TET2, ASXL1, IDH1 and IDH2, CBL, and DNMT3A mutations, CBF fusion genes, levels of BAALC, ERG, EVI1, MN1, and APP microarray gene-expression, microRNA gene-expression signature, levels of methylation of genes silenced in AML, and genomic DNA by PCR amplification, RT-PCR, and denaturing high-performance liquid chromatography.
- interventionNames
- Genetic: DNA analysis
- Genetic: DNA methylation analysis
- Genetic: gene expression analysis
- Genetic: mutation analysis
- Genetic: polymerase chain reaction
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: high performance liquid chromatography
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols
- timeFrame
- baseline
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * Tissue samples from previously untreated patients with AML considered for enrollment onto ongoing and future CALGB treatment protocols * AML tissue samples from companion Leukemia Tissue Bank protocol CALGB-9665 and the companion cytogenetic protocol CALGB-8461 * AML diagnostic bone marrow and/or blood samples from patients enrolled on CLB-9720, CLB-9621 (all cytogenetic subtypes), and CALGB-19808 (abnormal cytogenetics only)
References
Publications (9)
- RESULTBecker H, Marcucci G, Maharry K, Radmacher MD, Mrozek K, Margeson D, Whitman SP, Paschka P, Holland KB, Schwind S, Wu YZ, Powell BL, Carter TH, Kolitz JE, Wetzler M, Carroll AJ, Baer MR, Moore JO, Caligiuri MA, Larson RA, Bloomfield CD. Mutations of the Wilms tumor 1 gene (WT1) in older patients with primary cytogenetically normal acute myeloid leukemia: a Cancer and Leukemia Group B study. Blood. 2010 Aug 5;116(5):788-92. doi: 10.1182/blood-2010-01-262543. Epub 2010 May 4. PMID 20442368
- DERIVEDOzga M, Nicolet D, Mrozek K, Walker CJ, Blachly JS, Kohlschmidt J, Orwick S, Carroll AJ, Larson RA, Kolitz JE, Powell BL, Stone RM, Byrd JC, Eisfeld AK, Mims AS. White blood cell count levels are associated with inflammatory response and constitute independent outcome predictors in adult patients with acute myeloid leukemia aged <60 years. Am J Hematol. 2024 Nov;99(11):2236-2240. doi: 10.1002/ajh.27465. Epub 2024 Sep 16. No abstract available. PMID 39283025
- DERIVEDArcher KJ, Fu H, Mrozek K, Nicolet D, Mims AS, Uy GL, Stock W, Byrd JC, Hiddemann W, Braess J, Spiekermann K, Metzeler KH, Herold T, Eisfeld AK. Identifying long-term survivors and those at higher or lower risk of relapse among patients with cytogenetically normal acute myeloid leukemia using a high-dimensional mixture cure model. J Hematol Oncol. 2024 May 3;17(1):28. doi: 10.1186/s13045-024-01553-6. PMID 38702786
- DERIVEDOzga M, Nicolet D, Mrozek K, Yilmaz AS, Kohlschmidt J, Larkin KT, Blachly JS, Oakes CC, Buss J, Walker CJ, Orwick S, Jurinovic V, Rothenberg-Thurley M, Dufour A, Schneider S, Sauerland MC, Gorlich D, Krug U, Berdel WE, Woermann BJ, Hiddemann W, Braess J, Subklewe M, Spiekermann K, Carroll AJ, Blum WG, Powell BL, Kolitz JE, Moore JO, Mayer RJ, Larson RA, Uy GL, Stock W, Metzeler KH, Grimes HL, Byrd JC, Salomonis N, Herold T, Mims AS, Eisfeld AK. Sex-associated differences in frequencies and prognostic impact of recurrent genetic alterations in adult acute myeloid leukemia (Alliance, AMLCG). Leukemia. 2024 Jan;38(1):45-57. doi: 10.1038/s41375-023-02068-8. Epub 2023 Nov 28. PMID 38017103
- DERIVEDRebechi M, Kohlschmidt J, Mrozek K, Nicolet D, Mims AS, Blachly JS, Orwick S, Larkin KT, Oakes CC, Hantel A, Carroll AJ, Blum WG, Powell BL, Uy GL, Stone RM, Larson RA, Byrd JC, Paskett ED, Plascak JJ, Eisfeld AK. Association of social deprivation with survival in younger adult patients with AML: an Alliance study. Blood Adv. 2023 Aug 8;7(15):4019-4023. doi: 10.1182/bloodadvances.2022009325. No abstract available.