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BIOMARKER:

Chr del(11q)

9d
IGHV mutational status and BCR stereotypy in chronic lymphocytic leukemia: A Turkish cohort analysis. (PubMed, Ann Hematol)
CLL in Türkiye demonstrates region-specific immunogenetic features while preserving established clinico-biological correlations. Integration of IGHV status, cytogenetics, and BCR stereotypy may improve risk stratification in underrepresented populations.
Journal
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IGH (Immunoglobulin Heavy Locus)
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Chr del(11q) • IGH mutation
15d
Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=49, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2027
Trial completion date
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Chr del(11q)
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lenalidomide
21d
Long-term outcomes of first-line iFCR regimen in chronic lymphocytic leukemia/small lymphocytic lymphoma and the role of MRD (PubMed, Zhonghua Xue Ye Xue Za Zhi)
Objective: This study aimed to investigate the clinical significance of measurable residual disease (MRD) in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) treated with ibrutinib plus fludarabine, cyclophosphamide, and rituximab (iFCR) regimen. Furthermore, the ibrutinib maintenance strategy can be adjusted based on the BM-MRD level at 2 years. Monitoring PB-MRD dynamically was crucial in detecting MRD conversion and progression.
Retrospective data • Journal
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TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
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TP53 mutation • Chr del(11q) • IGH mutation
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Imbruvica (ibrutinib) • Rituxan (rituximab) • cyclophosphamide • fludarabine IV
2ms
Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=42, Completed, Jennifer Woyach | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Jan 2026
Trial completion • Trial completion date
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TP53 (Tumor protein P53)
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Chr del(11q)
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Imbruvica (ibrutinib)
2ms
The Evaluation of Neurotrophic Receptor Tyrosine Kinase (NTRK) Alterations in Neuroblastomas. (PubMed, Front Biosci (Schol Ed))
Owing to the presence of neural tissue, NTRKs are highly positive in IHC, making these genes unsuitable as biomarkers for assessing NTRK inhibitor sensitivity and resistance, which are tissue-agnostic drugs. The observed low fusion rate is consistent with the literature, and the significance of the numerous point mutations identified as agnostic markers warrants further investigation. NTRK expression, fusion, and point mutations were not associated with clinical parameters or survival.
Journal
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NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NTRK (Neurotrophic receptor tyrosine kinase)
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Chr del(11q) • MYCN amplification • NTRK positive • NTRK fusion
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Vitrakvi (larotrectinib) • Rozlytrek (entrectinib)
3ms
GFH009X2101: Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML (clinicaltrials.gov)
P1/2, N=160, Recruiting, Sellas Life Sciences Group | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2) • DDX41 (DEAD-Box Helicase 41) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
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TP53 mutation • KRAS mutation • FLT3-ITD mutation • Chr del(17p) • IDH1 mutation • IDH2 mutation • FLT3 mutation • TP53 wild-type • NPM1 mutation • KRAS wild-type • Chr del(11q) • ASXL1 mutation • SF3B1 mutation • EZH2 mutation • NRAS wild-type • SRSF2 mutation • IDH wild-type
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Venclexta (venetoclax) • azacitidine • tambiciclib (SLS009)
3ms
Short and complex-Telomeres and genomes in CLL. (PubMed, Br J Haematol)
Br J Haematol 2026 (Online ahead of print). doi: 10.1111/bjh.70317.
Journal
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IGH (Immunoglobulin Heavy Locus)
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Chr del(11q) • IGH mutation
3ms
High-risk molecular features may eclipse genomic complexity in predicting chronic lymphocytic leukemia outcomes; UK clinical trial insights. (PubMed, Leukemia)
HGC may reflect a convergence of high-risk features rather than represent an independent biomarker. The interplay of telomere attrition, IGHV status and DNA methylation subtype necessitates further validation in targeted therapy cohorts to enhance risk assessment in prognostic models.
Journal
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TP53 (Tumor protein P53) • NOTCH1 (Notch 1) • BIRC3 (Baculoviral IAP repeat containing 3)
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TP53 wild-type • Chr del(11q)
3ms
Enrollment open • Trial initiation date • Minimal residual disease
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TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
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TP53 mutation • Chr del(11q)
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clonoSEQ®
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Venclexta (venetoclax) • Gazyva (obinutuzumab) • Epkinly (epcoritamab-bysp)
4ms
Real-world disease characteristics and frontline treatments used in chronic lymphocytic leukaemia in Bulgaria: An observational cohort study (DESCRIBE). (PubMed, J Int Med Res)
Improving the rate of testing for specific high-risk molecular and genetic markers is vital to enhancing outcomes in patients with chronic lymphocytic leukaemia. In the era of proven efficacy of targeted agents, chemoimmunotherapy should be discouraged, in line with international guidelines.
Observational data • Journal • Real-world evidence • IO biomarker
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TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • IGH (Immunoglobulin Heavy Locus)
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Chr del(11q) • IGH mutation
4ms
Optical Genome Mapping Enhances Structural Variant Detection and Refines Risk Stratification in Chronic Lymphocytic Leukemia. (PubMed, Genes (Basel))
Combining OGM and NGS analysis refined risk stratification beyond standard FISH panels and supports more precise, individualized management strategies in CLL. Prospective studies are warranted to evaluate the clinical utility of OGM-guided genomic profiling in contemporary treatment paradigms.
Journal • IO biomarker
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TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1) • IGH (Immunoglobulin Heavy Locus) • BIRC3 (Baculoviral IAP repeat containing 3) • BCL3 (BCL3 Transcription Coactivator) • MIR16 (MicroRNA 16) • MIR15A (MicroRNA 15a) • MIR16-1 (MicroRNA 16-1)
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Chr del(11q) • IGH mutation • RB1 deletion
5ms
Measurable residual disease-guided combination of ibrutinib plus venetoclax versus FCR in previously untreated patients with intermediate-risk chronic lymphocytic leukaemia: a phase 2, randomised trial (ERADIC) from the FILO group. (PubMed, EClinicalMedicine)
We compared an MRD-guided, fixed-duration ibrutinib-venetoclax (IV) regimen to fludarabine-cyclophosphamide-rituximab (FCR) in this population. A patient profile suitable for an MRD-guided, fixed-duration IV regimen requires consideration of potential toxicities. Abbvie and Janssen France.
P2 data • Journal
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TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
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Chr del(11q)
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • cyclophosphamide • fludarabine IV