Cited by 1,128Chronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and TreatmentCutaneous lymphoproliferative disorders research

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Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies

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Advani, Ranjana H., Buggy, Joseph J., Sharman, Jeff P., Smith, Sonali M., Boyd, Thomas E., Grant, Barbara, Kolibaba, Kathryn S., Furman, Richard R., Rodriguez, Sara, Chang, Betty Y., Sukbuntherng, Juthamas, Izumi, Raquel, Hamdy, Ahmed, Hedrick, Eric, Fowler, Nathan H.·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.42.7906PMC PMC5505166

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Abstract

Purpose: Survival and progression of mature B-cell malignancies depend on signals from the B-cell antigen receptor, and Bruton tyrosine kinase (BTK) is a critical signaling kinase in this pathway. We evaluated ibrutinib (PCI-32765), a small-molecule irreversible inhibitor of BTK, in patients with B-cell malignancies. Patients and Methods: Patients with relapsed or refractory B-cell lymphoma and chronic lymphocytic leukemia received escalating oral doses of ibrutinib. Two schedules were evaluated: one, 28 days on, 7 days off; and two, once-daily continuous dosing. Occupancy of BTK by ibrutinib in peripheral blood was monitored using a fluorescent affinity probe. Dose escalation proceeded until either the maximum-tolerated dose (MTD) was achieved or, in the absence of MTD, until three dose levels above full BTK occupancy by ibrutinib. Response was evaluated every two cycles. Results: Fifty-six patients with a variety of B-cell malignancies were treated over seven cohorts. Most adverse events were grade 1 and 2 in severity and self-limited. Dose-limiting events were not observed, even with prolonged dosing. Full occupancy of the BTK active site occurred at 2.5 mg/kg per day, and dose escalation continued to 12.5 mg/kg per day without reaching MTD. Pharmacokinetic data indicated rapid absorption and elimination, yet BTK occupancy was maintained for at least 24 hours, consistent with the irreversible mechanism. Objective response rate in 50 evaluable patients was 60%, including complete response of 16%. Median progression-free survival in all patients was 13.6 months. Conclusion: Ibrutinib, a novel BTK-targeting inhibitor, is well tolerated, with substantial activity across B-cell histologies.

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Ibrutinib: A New Targeted Therapy for Hematologic Cancers
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Efficacy of Ibrutinib-Based Regimen in Chronic Lymphocytic Leukemia: A Systematic Review
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BackgroundResultInfluential
Lenalidomide in relapsed refractory non-Hodgkin′s lymphoma: An Indian perspective
Lakshmaiah, K. C., Shetty, K. S. R., Sathyanarayanan, V., Lokanatha, D., Abraham, L. J., & Babu, K. G. (2015) · Journal of Cancer Research and Therapeutics · doi:10.4103/0973-1482.151418 · Cited by 7
How I treat rituximab refractory patients with WM
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Tumor microenvironment as a novel therapeutic target for lymphoid leukemias
Mousavi, S., Nouri, S., Sadeghipour, A., & Atashi, A. (2025) · Annals of Hematology · doi:10.1007/s00277-025-06237-w · Cited by 6
The clinical safety of ibrutinib in chronic lymphocytic leukemia
Molica, S. (2015) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2015.1084286 · Cited by 6
“, the mean terminal half-life ranged from 4 to 8 h); however, BTK occupancy was maintained for at least 24 h which is consistent with the irreversible mechanism [28].”
Background
Quantitative real time PCR analysis of apoptotic gene expression in chronic lymphocytic leukemia patients and their relationships with chemosensitivity
Saaed, H., Mahmood, M. A., & Khoshnaw, N. (2017) · Applied cancer research/Applied Cancer Research · doi:10.1186/s41241-017-0014-z · Cited by 6
“The treatment of relapsed chronic lymphocytic leukemia (CLL) has recently changed with the introduction of drugs that inhibit intracellular B-cell receptor signaling [20].”
Background
Discovery of Affinity‐Based Probes for Btk Occupancy Assays
Qiu, H., Caldwell, R. D., Liu‐Bujalski, L., Goutopoulos, A., Jones, R. C., Potnick, J. R., Sherer, B., Bender, A. T., Grenningloh, R., Xu, D., et al. (2018) · ChemMedChem · doi:10.1002/cmdc.201800714 · Cited by 6
Keeping a balance in chronic lymphocytic leukemia (CLL) patients taking ibrutinib: ibrutinib-associated adverse events and their management based on drug interactions
Cho, H. J., Baek, D. W., Kim, J., Lee, J. M., Moon, J. H., & Sohn, S. K. (2021) · Expert Review of Hematology · doi:10.1080/17474086.2021.1967139 · Cited by 6
Integrating New Therapies for Chronic Lymphocytic Leukemia
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Discovery of pyrido[3,4-b]indol-1-one derivatives as novel non-covalent Bruton’s tyrosine kinase (BTK) inhibitors
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A radiologist’s guide to novel anticancer therapies in the era of precision medicine
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“9), which inhibits the BCR and cytokine receptor pathways [74,75].”
Background
BTK Inhibitors and Other Targeted Therapies in Waldenström Macroglobulinemia
Chohan, K. L., & Kapoor, P. (2023) · Hemato · doi:10.3390/hemato4020012 · Cited by 6
“involving patients with various B cell malignancies demonstrated an encouraging overall response in three of four patients with R/R WM, treated with oral ibrutinib monotherapy [20].”
Background
Synthesis, Antioxidant, Antifungal and Antibacterial Activities of New Class of Fused Isoxazole-Pyrimidines and Pyrazole-Pyrimidines as Five and Six Membered Heterocyclic Compounds
Saleh, E. A. M., Hassan, I., & Husain, K. (2023) · Russian Journal of Bioorganic Chemistry · doi:10.1134/s1068162023040167 · Cited by 6
Assessment of ibrutinib scheduling on leukocyte, lymph node size and blood pressure dynamics in chronic lymphocytic leukemia through pharmacokinetic‐pharmacodynamic models
Ibrahim, E., Karlsson, M. O., & Friberg, L. E. (2023) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.13010 · Cited by 6
“18 Laboratory tests and physical examinations were performed weekly for the first month, every other week for the second month, and thereafter monthly, whereas radiologic examinations were performed at the end of weeks 8, 20, 32, 48, 60, and 96.”
The potential of Bruton’s tyrosine kinase (BTK) inhibitors in the pharmacotherapeutic management of immune and dermatological disease
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“Apparently increased single dosages as well as BID dosing are being pursued in subsequent trials of AVL-292 to address this [56].”
BackgroundResultInfluential
Optimization of the efflux ratio and permeability of covalent irreversible BTK inhibitors
Qiu, H., Liu‐Bujalski, L., Caldwell, R. D., Follis, A. V., Gardberg, A. S., Goutopoulos, A., Grenningloh, R., Head, J. C., Johnson, T. L., Jones, C. C., et al. (2018) · Bioorganic & Medicinal Chemistry Letters · doi:10.1016/j.bmcl.2018.09.018 · Cited by 6
A review of bioanalytical methods for chronic lymphocytic leukemia drugs and metabolites in biological matrices
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Successful Long-Term Ibrutinib Treatment in a Hemodialysis Patient With Leukemic Nonnodal Mantle Cell Lymphoma
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A Phase I, Randomized, Double‐Blind, Placebo‐Controlled, Single‐Dose and Multiple‐Rising‐Dose Study of the BTK Inhibitor TAK‐020 in Healthy Subjects
Esfandiari, E., Chen, M., Smithson, G. M., Blair, D., Faessel, H. M., Wagner, J. A., McLean, L., & Fedyk, E. R. (2021) · Clinical and Translational Science · doi:10.1111/cts.12871 · Cited by 6
Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial
Balasubramanian, S., Hodkinson, B. P., Schuster, S. J., Fowler, N. H., Trotman, J., Heß, G., Cheson, B. D., Schäffer, M., Sun, S. H., Deshpande, S., et al. (2021) · Cancer Medicine · doi:10.1002/cam4.4422 · Cited by 6
Self-citation
Novel Agents in Mantle Cell Lymphoma
Kumar, A. A. (2015) · Current Oncology Reports · doi:10.1007/s11912-015-0460-2 · Cited by 6
Best Practice & Research Clinical Haematology
Jeyakumar, D., & O'Brien, S. M. (2016) · Cited by 6
Ibrutinib-induced polyneuropathy: A case report
Cömert, P., Albayrak, M., Yıldız, A., Sahin, O. Z., Öztürk, H. B. A., & Aras, M. R. (2020) · Journal of Oncology Pharmacy Practice · doi:10.1177/1078155220903357 · Cited by 6
Time-Resolved scRNA-Seq Tracks the Adaptation of a Sensitive MCL Cell Line to Ibrutinib Treatment
Fuhr, V., Vafadarnejad, E., Dietrich, O., Arampatzi, P., Riedel, A., Saliba, A., Rosenwald, A., & Rauert‐Wunderlich, H. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22052276 · Cited by 6
Double Strike in Chronic Lymphocytic Leukemia—The Combination of BTK and BCL2 Inhibitors in Actual and Future Clinical Practice
Zygmunciak, P., Dancewicz, H., Stróżna, K., Błażowska, O., Bieliński, K., Robak, T., & Puła, B. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26073193 · Cited by 5
“The median progression-free survival (PFS) for the entire cohort was 13.6 months [19].”
Influential
Dogs as a Model for Cancer: An Update
Fenger, J. M., & London, C. A. (2026) · Annual Review of Animal Biosciences · doi:10.1146/annurev-animal-111523-101930 · Cited by 5
Zanubrutinib plus R-CHOP improves the treatment effect of newly diagnosed diffuse large B cell lymphoma with double expression of MYC and BCL-2
Zhang, M., Wu, Y., Cheng, Z., Zhang, L., Liu, L., Liu, F., Cui, G., Xia, L., Hu, Y., Mei, H., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1526318 · Cited by 5
B cell receptor pathway in chronic lymphocytic leukemia: specific role of CC-292
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“In the 14 patients with CLL, the overall response rate (ORR) was 79%.(24) Given the success of the Phase I trial, ibrutinib is being investigated as a single agent in relapsed and refractory CLL and in combination studies with rituximab (NCT01520519),(25) lenalidomide (NCT01886859),(26) BR or FCR (the FCR arm closed e…”
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van der Jagt, R. (2013) · Expert Review of Hematology · doi:10.1586/17474086.2013.841538 · Cited by 5
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[Ibrutinib inhibits mesenchymal stem cells-mediated drug resistance in diffuse large B-cell lymphoma].
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Modeling the B‐cell receptor signaling on single cell level reveals a stable network circuit topology between nonmalignant B cells and chronic lymphocytic leukemia cells and between untreated cells and cells treated with kinase inhibitors
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“Resistance mechanisms to the novel treatments lead to relapse in CLL patients, which is why understanding BCR signaling in CLL is especially important.(21,25,26) Interestingly, patients with U-CLL do not differ from M-CLL patients in clinical prognosis under BTK or LYN inhibition.”
Result
Ibrutinib combined with low‐dose histone deacetylases inhibitor chidamide synergistically enhances the anti‐tumor effect in B‐cell lymphoma
Yu, H., Mi, L., Zhang, W., Ye, Y., Li, M., Hu, D., Cao, J., Wang, D., Wang, X., Ding, N., et al. (2022) · Hematological Oncology · doi:10.1002/hon.3056 · Cited by 4
A Workflow Combining Machine Learning with Molecular Simulations Uncovers Potential Dual-Target Inhibitors against BTK and JAK3
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“A few BTK inhibitors, including ibrutinib [15,16], orelabrutinib [17], and pirtobrutinib [18,19], have been approved by the US Food and Drug Administration (FDA), and several new ones are at different stages of trials (Figure A1b).”
Background
A highly selective PI3Kδ inhibitor BGB-10188 shows superior preclinical anti-tumor activities and decreased on-target side effects on colon
Yang, X. F., Bai, H., Yuan, X., Yang, X., Liu, Y., Guo, M., Hu, N., Jiang, B., Lian, Z., Ma, Z., et al. (2024) · Neoplasia · doi:10.1016/j.neo.2024.101053 · Cited by 5
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Background
Non-Hodgkin Lymphoma
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“1 Ibrutinib with ofatumumab Based on the excellent results obtained with the Bruton’s tyrosine kinase inhibitor ibrutinib [70,71] in patients with relapsed and refractory CLL, this agent has been combined with ofatumumab, the anti-CD20 mAb in patients with RS.”
BackgroundResult
Oncogenic Signaling Pathways and Pathway-Based Therapeutic Biomarkers in Lymphoid Malignancies
Sun, R., Wang, J., & Young, K. H. (2017) · Critical Reviews™ in Oncogenesis · doi:10.1615/critrevoncog.2017020816 · Cited by 5
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Authors: Advani, R. H., Buggy, J. J., Sharman, J. P., Smith, S. M., Boyd, T. E., Grant, B., Kolibaba, K. S., Furman, R. R., Rodriguez, S., Chang, B. Y., Sukbuntherng, J., Izumi, R., Hamdy, A., Hedrick, E., & Fowler, N. H.
Affiliations: University of Vermont (US)
Corresponding author: Advani, Ranjana H.
ORCID: Advani, Ranjana H.
Sharman, Jeff P.
Smith, Sonali M.
Kolibaba, Kathryn S.
Furman, Richard R.
Chang, Betty Y.
Izumi, Raquel
Hamdy, Ahmed
Fowler, Nathan H.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-01-01
Volume: 31
Issue: 1
Pages: 88-94
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.42.7906
PMC: PMC5505166
OpenAlex: W2171771895
Cited by: 1,128
References: 32
Citations by year: 2026: 17 · 2025: 38 · 2024: 47 · 2023: 44 · 2022: 46 · 2021: 90 · 2020: 79 · 2019: 92 · 2018: 73 · 2017: 117 · 2016: 94 · 2015: 135 · 2014: 134 · 2013: 110
FWCI: 58.95
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Abbott Laboratories
GlaxoSmithKline
Gilead Sciences
Celgene
Genentech
Takeda Oncology
Pharmacyclics
National Cancer Institute (P30CA016672)
Topics: Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Health Sciences › Medicine › Dermatology › Cutaneous lymphoproliferative disorders research
Keywords: ibrutinib, BTK inhibitors, relapsed/refractory B-cell malignancies, B-cell lymphoma, chronic lymphocytic leukemia, B cell receptor signaling, irreversible kinase inhibitors, BTK occupancy, dose-limiting toxicity, pharmacokinetics, progression-free survival
MeSH terms: Agammaglobulinaemia Tyrosine Kinase, Adenine, Administration, Oral, Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Piperidines, Prognosis, Protein-Tyrosine Kinases, Pyrazoles, Pyrimidines, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Salvage Therapy, Drug Resistance, Neoplasm, Maximum Tolerated Dose, Protein Kinase Inhibitors

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Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies

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