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Management of adverse events associated with idelalisib treatment – expert panel opinion



Read More: http://informahealthcare.com/doi/abs/10.3109/10428194.2015.1022770
Management of adverse events associated with idelalisib treatment – expert panel opinion



Read More: http://informahealthcare.com/doi/abs/10.3109/10428194.2015.1022770
Management of adverse events associated with idelalisib treatment – expert panel opinion



Read More: http://informahealthcare.com/doi/abs/10.3109/10428194.2015.1022770
Management of adverse events associated with idelalisib treatment – expert panel opinion



Read More: http://informahealthcare.com/doi/abs/10.3109/10428194.2015.1022770
Blood 2015
Randomized phase II study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia (CLL).

Blood 2015
Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older.

Leukemia and Lymphoma 2015
Management of adverse events associated with idelalisib treatment - expert panel opinion

Blood 2015
An open-label phase 2 trial of entospletinib (GS-9973), a selective Syk inhibitor, in chronic lymphocytic leukemia

Blood 2015
Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression.

Cancer Discovery 2014
Cell-Cycle Reprogramming for PI3K Inhibition Overrides a Relapse-Specific C481S BTK Mutation Revealed by Longitudinal Functional Genomics in Mantle Cell Lymphoma

Clinical Lymphoma Myeloma and Leukemia 2014
Vemurafenib response in two patients with post-transplant refractoryBRAF V600E mutated multiple myeloma

Case Reports in Oncology 2014


Blood 2014
Objective responses in relapsed T-cell lymphomas with single agent brentuximab vedotin.

New England Journal of Medicine 2014
Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia

Lancet Oncology 2014
Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial

Blood 2014
Ibrutinib is an irreversible molecular inhibitor of ITK driving a Th1 selective pressure in T-lymphocytes.

New England Journal of Medicine 2013
Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia

Supportive Care Cancer 2013
Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.

Journal of Clinical Oncology 2012 Oct 22
Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies.

Proc Natl Acad Sci  2010 Jul 20;107(29):12747-54.
B-cell signaling networks reveal a negative prognostic human lymphoma cell subset that emerges during tumor progression.

2010 Apr 1;115(13):2578-85.
Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia.

2009 Sep 1;122(Pt 17):3137-44. Epub 2009 Aug 4.
Engagement of CD81 induces ezrin tyrosine phosphorylation and its cellular redistribution with filamentous actin.

2007 Jul;22(7):997-1002. Epub 2007 May 3.
Effectiveness of warfarin among patients with cancer.

2004 Jun 15;100(12):2664-70.
Gemcitabine-associated thrombotic microangiopathy.


Presented Abstracts


ASCO 2014

Independent evaluation of ibrutinib efficacy 3 years post-initiation of monotherapy in patients with chronic lymphocytic leukemia/small lymphocytic leukemia including deletion 17p disease.

A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of idelalisib (GS-1101) in combination with bendamustine and rituximab for previously treated chronic lymphocytic leukemia (CLL).

Second interim analysis of a phase 3 study evaluating idelalisib and rituximab for relapsed CLL.

Health-related quality of life (HRQL) impact of idelalisib (IDELA) in patients (pts) with relapsed chronic lymphocytic leukemia (CLL): Phase 3 results.

Obinutuzumab (GA101) 1,000 mg versus 2,000 mg in patients with chronic lymphocytic leukemia (CLL): Results of the phase II GAGE (GAO4768g) trial.

Efficacy of idelalisib in CLL subpopulations harboring del(17p) and other adverse prognostic factors: Results from a phase 3, randomized, double-blind, placebo-controlled trial.

MAGNIFY: A phase 3B, randomized trial of lenalidomide plus rituximab induction and maintenance therapy followed by lenalidomide single-agent versus rituximab maintenance in patients with relapsed/refractory indolent non-Hodgkin lymphoma (NHL).

Effect of clinical NGS-based cancer genomic profiling on physician treatment decisions in advanced solid tumors.

Phase 2 trial of GS-9973, a selective Syk inhibitor, in chronic lymphocytic leukemia (CLL).

Preliminary results of a phase II randomized study (ROMULUS) of polatuzumab vedotin (PoV) or pinatuzumab vedotin (PiV) plus rituximab (RTX) in patients (Pts) with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).


ASH 2013

Clinical Activity Of Idelalisib (GS-1101), a Selective Inhibitor Of PI3Kδ, In Phase 1 and 2 Trials In Chronic Lymphocytic Leukemia (CLL): Effect Of Del(17p)/TP53 Mutation, Del(11q), IGHV Mutation, and NOTCH1 Mutation

Phase 1 Study Of Single Agent CC-292, a Highly Selective Bruton’s Tyrosine Kinase (BTK) Inhibitor, In Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)


The Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Monotherapy Demonstrates Long-Term Safety and Durability Of Response In Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Patients In An Open-Label Extension Study


A Phase 1 Study Of The Selective PI3Kδ Inhibitor Idelalisib (GS-1101) In Combination With Therapeutic Anti-CD20 Antibodies (Rituximab or Ofatumumab) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia


Chemo-Immunotherapy Combination Of Idelalisib With Bendamustine/Rituximab Or Chlorambucil/Rituximab In Patients With Relapsed/Refractory CLL Demonstrates Efficacy and Tolerability


Idelalisib, a Selective Inhibitor Of PI3Kδ, In Combination With Bendamustine, Fludarabine Or Chlorambucil In Patients With Relapsed Or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)


Phase 2 Trial Of GS-9973, a Selective Syk Inhibitor, In Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)


A Phase 2 Study Of Brentuximab Vedotin In Patients With Relapsed Or Refractory CD30-Positive Non-Hodgkin Lymphomas:  Interim Results In Patients With DLBCL and Other B-Cell Lymphomas


A Phase 2 Study Of Single-Agent Brentuximab Vedotin For Front-Line Therapy Of Hodgkin Lymphoma In Patients Age 60 Years and Above:  Interim Results


International Conference on Malignant Lymphoma (Lugano) 


Abstract P100: PHASE 1B STUDY OF IDELALISIB (GS-1101) PLUS CHLORAMBUCIL ± RITUXIMAB IN PATIENTS WITH RELAPSED AND REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) (View abstract)

Abstract S520: PHASE 1 STUDY OF SINGLE AGENT CC-292, A HIGHLY SELECTIVE BRUTON’S TYROSINE KINASE (BTK) INHIBITOR, IN RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND B-CELL NON-HODGKIN LYMPHOMA (B-NHL) (View abstract)


Abstract S1150: UPDATE ON A PHASE 1 STUDY OF THE SELECTIVE PI3K-DELTA INHIBITOR, IDELALISIB (GS-1101) IN COMBINATION WITH OFATUMUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (View abstract)

ASCO 2013


Tolerability and activity of combinations of the PI3Kδ inhibitor idelalisib (GS-1101) with rituximab and/or bendamustine in patients with previously treated, indolent non-Hodgkin lymphoma (iNHL): Updated results from a phase I study.

Update on a phase I study of the selective PI3Kδ inhibitor idelalisib (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory CLL.




ASH 2012

Combinations of the Phosphatidylinositol 3-Kinase-Delta (PI3Kδ) Inhibitor Gs‑1101 (CAL-101) with Rituximab and/or Bendamustine Are Tolerable and Highly Active in Previously Treated, Indolent Non-Hodgkin Lymphoma: Results From a Phase I Study

Variation in Health-Related Quality of Life by Line of Therapy of Patients with Chronic Lymphocytic Leukemia

The Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Promotes High Response Rate, Durable Remissions, and Is Tolerable in Treatment Naïve (TN) and Relapsed or Refractory (RR) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Patients Including Patients with High-Risk (HR) Disease: New and Updated Results of 116 Patients in a Phase Ib/II Study


Combinations of the Selective Phosphatidylinositol 3-Kinase-Delta (PI3Kdelta) Inhibitor GS–1101 (CAL-101) with Rituximab and/or Bendamustine Are Tolerable and Highly Active in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL): Results From a Phase I Study


A Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas:  Interim Results


The Bruton’s Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Is Active and Tolerated in Relapsed Follicular Lymphoma



German CLL Research Group (Invited Lecture - Sept 2012

Safety and Efficacy of GS-1101 alone or in combination with bendamustine and/or rituxan for patients with CLL

ASCO 2012 Research


Phase Ib trial of AVL-292, a covalent inhibitor of Bruton's tyrosine kinase (Btk), in chronic lymphocytic leukemia (CLL) and B-non-Hodgkin lymphoma (B-NHL).


CD30 expression in nonlymphomatous malignancies.


The Bruton's tyrosine kinase (BTK) inhibitor PCI-32765 (P) in treatment-naive (TN) chronic lymphocytic leukemia (CLL) patients (pts): Interim results of a phase Ib/II study.


Activity and tolerability of the Bruton's tyrosine kinase (Btk) inhibitor PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Interim results of a phase Ib/II study.


A phase I/II study of the selective phosphatidylinositol 3-kinase-delta (PI3Kδ) inhibitor, GS-1101 (CAL-101), with ofatumumab in patients with previously treated chronic lymphocytic leukemia (CLL).


Variation in health-related quality of life (HRQOL) by ECOG performance status (PS) and fatigue among patients with chronic lymphocytic leukemia (CLL).



ASH 2011

1787 A Phase 1 Study of the Selective Phosphatidylinositol 3-Kinase-Delta (PI3Kδ) Inhibitor, CAL-101 (GS-1101), in Combination with Rituximab and/or Bendamustine in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

2864 Patterns of Care for Patients with Chronic Lymphocytic Leukemia (CLL): The Connect® CLL Disease Registry


983 The Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 Induces Durable Responses in Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Follow-up of a Phase Ib/II Study


2699 A Phase 1 Study of the Selective Phosphatidylinositol 3-Kinase-Delta (PI3Kδ) Inhibitor, Cal-101 (GS-1101), in Combination with Rituximab and/or Bendamustine in Patients with Previously Treated, Indolent Non-Hodgkin Lymphoma (iNHL)


2085 Variation in Health-Related Quality of Life by Age Among Patients with Chronic Lymphocytic Leukemia



ASCO 2011

Activity and tolerability of the Bruton's tyrosine kinase (Btk) inhibitor PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Interim results of a phase Ib/II study.


ASH 2010

The Btk Inhibitor, PCI-32765, Induces Durable Responses with Minimal Toxicity In Patients with Relapsed/Refractory B-Cell Malignancies: Results From a Phase I Study

The Bruton's Tyrosine Kinase Inhibitor, PCI-32765, Is Well Tolerated and Demonstrates Promising Clinical Activity In Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL): An Update on Ongoing Phase 1 Studies



ASCO 2010

Effect of Btk inhibitor PCI-32765 monotherapy on responses in patients with relapsed aggressive NHL: Evidence of antitumor activity from a phase I study.


ASH 2008 (Plenary Session)

Fostamatinib Disodium (FosD), An Oral Inhibitor of Syk, Is Well-Tolerated and Has Significant Clinical Activity in Diffuse Large B Cell Lymphoma (DLBCL) and Chronic Lymphocytic Leukemia (SLL/CLL)


ASH 2007

Syk Kinase Inhibition by R406 Inhibits BCR Mediated B Cell Proliferation and Interferes with BCR Signal Transduction in Primary Tumor Samples.

A Profile of 648 Signaling Network Events Identifies Cell Subsets with Diverse, Abnormal Responses to Lymphocyte Stimuli within Follicular Lymphoma Tumors.



ASCO 2007

Targeting syk kinase for the treatment of B-cell lymphoma.


Editorials



Clinical Oncology News December 2012