^
4d
Enrollment change
|
BGB-16673
13d
Trial completion • Surgery
|
CD20 negative
|
Keytruda (pembrolizumab)
13d
Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA. (PubMed, J Clin Oncol)
Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.
Journal
|
IGH (Immunoglobulin Heavy Locus)
|
IGH mutation
|
Rituxan (rituximab) • Brukinsa (zanubrutinib) • bendamustine
17d
A Long-term Extension Study of PCI-32765 (Ibrutinib) (clinicaltrials.gov)
P3, N=700, Recruiting, Janssen Research & Development, LLC | Enrolling by invitation --> Recruiting
Enrollment status
|
Imbruvica (ibrutinib)
20d
New P1 trial
26d
Enrollment change
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CD20 expression • CD19 expression
|
clonoSEQ
|
Venclexta (venetoclax) • Jaypirca (pirtobrutinib)
1m
CELESTIAL-TNCLL: An Ongoing, Open-Label, Multiregional, Phase 3 Study of Sonrotoclax (BGB-11417) + Zanubrutinib vs Venetoclax + Obinutuzumab for Treatment-Naive CLL (ASH 2024)
Introduction : The combination of venetoclax, the first-generation BCL2 inhibitor, and ibrutinib, a BTK inhibitor, has demonstrated efficacy in patients with chronic lymphocytic leukemia (CLL) (Wierda et al. Other secondary endpoints include PFS as assessed by investigator (INV); CRR by INV; rate of uMRD4 based on flow cytometry; overall response rate by IRC and INV; duration of response by IRC and INV; patient-reported outcomes; and safety and tolerability. Recruitment is ongoing at approximately 230 study sites in 20 countries, including 50 sites in the US, 6 in Brazil, and 15 in Canada.
Clinical • P3 data • IO biomarker
|
TP53 (Tumor protein P53)
|
TP53 mutation • TP53 mutation + Chr del(17p)
|
clonoSEQ
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • sonrotoclax (BGB-11417)
1m
Acalabrutinib and Venetoclax (AV) Combination for 2 Years for Patients with Previously Treated CLL/SLL - the Avenue-2 Trial (ASH 2024)
Clinical trials that studied the combination of the first generation BTKi ibrutinib and V have shown the feasibility and efficacy of the regimen. Given the favorable safety profile and sustained efficacy of acalabrutinib, combination regimens with venetoclax without (AV) or with obinutuzumab [O] (AVO) have been studied in the first line setting, and favorable efficacy and safety have been reported...Patients with significant cardiovascular disease, absorption issues, active bleeding or history of bleeding diathesis or required/currently receiving anticoagulation with warfarin or equivalent vitamin K antagonists were excluded...Clinical responses including uMRD4 at the end of treatment and the safety profile will be assessed. The trial is actively enrolling at Fred Hutchinson Cancer Center/University of Washington.
Clinical • IO biomarker
|
clonoSEQ
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
1m
Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation from Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=30, Recruiting, Mayo Clinic | Trial completion date: Nov 2025 --> Jan 2027 | Trial primary completion date: Nov 2024 --> Jan 2027
Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • IGH (Immunoglobulin Heavy Locus) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Imfinzi (durvalumab) • Calquence (acalabrutinib)
1m
Enrollment closed
|
Venclexta (venetoclax) • Rituxan (rituximab) • Jaypirca (pirtobrutinib) • Truxima (rituximab-abbs)
1m
IGHV (Immunoglobulin Heavy Chain Variable-Region) Gene Mutational Status Validation and Subsequent First-Year Experience (AMP 2024)
Based on our experience, SHM status can be achieved by routine NGS testing. Our first-year mutated-versus-unmutated test results are reasonably close to what is reported in the literature, supporting the effectiveness of this assay. The majority (66.6%) of QNS samples were due to lack of evidence of clonality in CLL samples.
IGH (Immunoglobulin Heavy Locus)
|
IGH mutation
|
LymphoTrack® Dx IGH Assay
2ms
Real World Experience with Time Limited Venetoclax and Obinutuzumab (VO) for Frontline Treatment of CLL/SLL with MRD Determination By Clonoseq® (ASH 2024)
Deep uMRD was revealed by ClonoSeq® in 12 out of 13 (92%) of pts tested. These data support the use of VO as a time-limited treatment option in both academic and community settings for CLL pts initiating frontline therapy.
Clinical • Real-world evidence • Real-world
|
clonoSEQ
|
Venclexta (venetoclax) • Gazyva (obinutuzumab)
2ms
Trial completion
|
Calquence (acalabrutinib)
2ms
Benefit VA: A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov)
P2, N=100, Not yet recruiting, VA Office of Research and Development | Trial completion date: Dec 2029 --> Dec 2030 | Trial primary completion date: Jun 2029 --> Jun 2030
Trial completion date • Trial primary completion date
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
2ms
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Jennifer R. Brown, MD, PhD | Trial primary completion date: Dec 2023 --> Dec 2026
Trial primary completion date
|
Calquence (acalabrutinib) • Ukoniq (umbralisib) • Briumvi (ublituximab-xiiy)
2ms
Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases (clinicaltrials.gov)
P=N/A, N=200, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date
|
KMT2A (Lysine Methyltransferase 2A) • IKZF1 (IKAROS Family Zinc Finger 1)
|
MLL rearrangement • MLL rearrangement
|
cyclophosphamide • fludarabine IV • cyclosporin A microemulsion
2ms
Enrollment closed
|
sonrotoclax (BGB-11417)
2ms
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
P=N/A, N=67, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=50 --> 67
Enrollment closed • Enrollment change
|
Calquence (acalabrutinib)
2ms
Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy (clinicaltrials.gov)
P2, N=4, Terminated, M.D. Anderson Cancer Center | N=44 --> 4 | Trial completion date: Jul 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Oct 2024; Slow Accrual
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1)
|
Arzerra (ofatumumab)
2ms
Clinicopathological characteristics and genomic profiling in patients with transformed lymphoma: a monocentric retrospective study. (PubMed, Ann Med)
Whole-exome sequencing and copy-number analysis revealed that tMZL derives from the divergent evolution of an ancestral common progenitor clone (CPC). Collectively, this study provides clinicopathological characteristics of three common types of transformed lymphomas and the genetic profile of tMZL with diagnostic and therapeutic implications.
Retrospective data • Journal
|
MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD79B (CD79b Molecule) • CREBBP (CREB binding protein) • CARD11 (Caspase Recruitment Domain Family Member 11) • EP300 (E1A binding protein p300) • TNFAIP3 (TNF Alpha Induced Protein 3)
2ms
Enrollment open • Combination therapy
|
Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
2ms
The clinical utility of plasma circulating tumor DNA in the diagnosis and disease surveillance in non-diffuse large B-cell non-Hodgkin lymphomas. (PubMed, Future Oncol)
Particularly, IGH-BCL2 and IGH-CCND1 fusions were concordant between plasma and tumor biopsies in FLs (91.1%) and MCLs (91.3%), respectively. Longitudinal data demonstrated that ctDNA clearance correlated with complete response but ctDNA increases preceded radiological relapses. ctDNA exhibited high concordance with tumor biopsy in detecting genetic aberrations and demonstrated potential as a promising noninvasive approach to disease surveillance in non-DLBCL NHLs.
Journal • IO biomarker • Circulating tumor DNA
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1)
|
Hemasalus™
2ms
A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (clinicaltrials.gov)
P2, N=27, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | N=50 --> 27
Trial completion • Enrollment change
|
CD19 (CD19 Molecule) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CCND1 overexpression
|
Zydelig (idelalisib) • Arzerra (ofatumumab)
2ms
Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant (clinicaltrials.gov)
P2, N=63, Recruiting, Thomas Jefferson University | Trial completion date: Oct 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
Trial completion date • Trial primary completion date
|
cyclophosphamide • melphalan • fludarabine IV
2ms
NCI-2021-03969: CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies (clinicaltrials.gov)
P1, N=25, Recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2024 --> Mar 2025
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
PLCG2 (Phospholipase C Gamma 2)
|
cyclophosphamide • bendamustine • fludarabine IV
2ms
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Jennifer R. Brown, MD, PhD | Trial primary completion date: Jan 2025 --> Dec 2023
Trial primary completion date
|
Calquence (acalabrutinib) • Ukoniq (umbralisib) • Briumvi (ublituximab-xiiy)
2ms
Enrollment closed
|
Venclexta (venetoclax) • Jaypirca (pirtobrutinib)
2ms
64Cu-LLP2A for Imaging Hematologic Malignancies (clinicaltrials.gov)
P1, N=42, Not yet recruiting, Washington University School of Medicine
New P1 trial
2ms
Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL (clinicaltrials.gov)
P2, N=45, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Sep 2024 --> Mar 2025
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule)
|
lenalidomide • Arzerra (ofatumumab)
3ms
CYTB323A12101: Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (clinicaltrials.gov)
P1/2, N=225, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> May 2028
Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Imbruvica (ibrutinib) • rapcabtagene autoleucel (YTB323)
3ms
A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies (clinicaltrials.gov)
P1/2, N=102, Completed, Oncternal Therapeutics, Inc | Active, not recruiting --> Completed
Trial completion
|
BCL2 (B-cell CLL/lymphoma 2)
|
Imbruvica (ibrutinib) • zilovertamab (UC-961)
3ms
Trial completion
|
Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
3ms
Sustained Benefit of Zanubrutinib vs Ibrutinib in Patients With R/R CLL/SLL: Final Comparative Analysis of ALPINE. (PubMed, Blood)
Incidence of atrial fibrillation/flutter was lower with zanubrutinib vs ibrutinib (7.1% vs 17.0%); no cardiac deaths were reported with zanubrutinib vs six cardiac deaths with ibrutinib. This analysis, at 42.5 months median follow-up, demonstrates that zanubrutinib remains more efficacious than ibrutinib with an improved overall safety/tolerability profile.
Journal
|
TP53 (Tumor protein P53)
|
TP53 mutation • TP53 mutation + Chr del(17p)
|
Imbruvica (ibrutinib) • Brukinsa (zanubrutinib)
3ms
Acalabrutinib in Combination with Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P2, N=52, Recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
3ms
NCI-2018-00315: Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CCND1 overexpression
|
Imbruvica (ibrutinib) • pevonedistat (MLN4924)
3ms
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=86, Active, not recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Sep 2025 --> Sep 2034
Trial completion date
|
TP53 (Tumor protein P53) • CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
TP53 mutation • CD20 expression • CD19 expression • TP53 expression
|
Imbruvica (ibrutinib)
3ms
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL (clinicaltrials.gov)
P2, N=29, Active, not recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Oct 2028 --> Oct 2034
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
|
Chr t(11;14) • CD20 expression • CD19 expression
|
Imbruvica (ibrutinib) • fludarabine IV
3ms
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
P2, N=15, Active, not recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Dec 2026 --> Dec 2025
Trial completion date • IO biomarker
|
TP53 (Tumor protein P53) • SF3B1 (Splicing Factor 3b Subunit 1)
|
TP53 mutation • NOTCH1 mutation • SF3B1 mutation
|
Keytruda (pembrolizumab) • Imbruvica (ibrutinib) • fludarabine IV
3ms
CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma (clinicaltrials.gov)
P1, N=8, Active, not recruiting, Joseph Tuscano | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Apr 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
|
lenalidomide • Gazyva (obinutuzumab) • Onureg (azacitidine oral)