Faculty

Danielle M. Brander, MD

Medical Instructor
Division of Hematologic Malignancies & Cellular Therapy
Department of Medicine
Duke University
Attending Physician, Hematologic Malignancies
Duke University Health System
Durham, North Carolina

Jeffrey P. DONOTUSESharman, MD

Medical Oncologist
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon

Jeff DONOTUSESharman, MD

Medical Director of Hematology Research
Willamette Valley Cancer Institute
US Oncology
Eugene, Oregon

Nicole Lamanna, MD

Associate Professor
Leukemia Service
Director of CLL Program
Hematologic Malignancies Section
Department of Medicine
New York-Presbyterian/Columbia University Medical Center
New York, New York

Provided by

Provided by Clinical Care Options, LLC

Supporters

Supported by an educational grant from

AstraZeneca

Target Audience

This program is intended for hematologists, hematologist-oncologists, and other clinicians involved in the management of patients with CLL and other B-cell malignancies.

Learning Objectives

Upon completion of this activity, participants should be able to:

Evaluate differences among agents targeting BTK in terms of molecular characteristics, selectivity, preclinical data, approved indications, dosing, safety profile, and efficacy
Delineate the variables to be considered in selecting treatment for CLL including tumor characteristics such as biomarkers and patient characteristics and preferences
Describe clinical trial results providing evidence for the important role of BTK inhibitor–based combinations in first-line treatment of CLL including phase III and phase II trials
Select patients most likely to benefit from continuous first-line treatment options and those patients most likely to benefit from time-limited first-line options
Plan optimal, individualized therapeutic strategies for patients with CLL taking into consideration recent practice-changing clinical trial results
Recognize and manage adverse events and toxicities associated with BTK inhibitor therapy to support adherence, appropriate dosing, quality of life, and continuation of treatment
Assess ongoing clinical trials evaluating currently available and emerging BTK inhibitors (and BTK-based combinations) to aid clinical trial enrollment and predict new options in the clinic

Disclosure

Clinical Care Options, LLC (CCO) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any relevant conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to CCO policy. CCO is committed to providing its learners with high-quality CME/CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity:

Faculty Disclosure

Primary Author

Danielle M. Brander, MD

Danielle M. Brander, MD, has disclosed that she has received consulting fees from AbbVie, AstraZeneca, Genentech, Pharmacyclics, Pfizer, Teva, and Verastem; funds for research support (paid to her institution) from AbbVie, ArQule, Ascentage, AstraZeneca, BeiGene, Bristol-Myers Squibb, Celgene, DTRM, Genentech, Juno, MEI Pharma, Pharmacyclics, TG Therapeutics, Tolero, and Verastem; and non-CME/CE fees from AbbVie, ArQule, Genentech, Pfizer, TG Therapeutics, and Verastem.

Jeffrey P. DONOTUSESharman, MD

Medical Oncologist
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon

Jeff P. Sharman, MD, has disclosed that he has received funds for research support from AbbVie, AstraZeneca, Genentech, Gilead Sciences, Pharmacyclics, and TG Therapeutics and consulting fees from AbbVie, AstraZeneca, Genentech, Pharmacyclics, and TG Therapeutics.

Jeff DONOTUSESharman, MD

Medical Director of Hematology Research
Willamette Valley Cancer Institute
US Oncology
Eugene, Oregon

Nicole Lamanna, MD

Associate Professor
Leukemia Service
Director of CLL Program
Hematologic Malignancies Section
Department of Medicine
New York-Presbyterian/Columbia University Medical Center
New York, New York

Nicole Lamanna, MD, has disclosed that she has received consulting fees from AbbVie, AstraZeneca, BeiGene, Celgene, Genentech, Gilead Sciences, Janssen, and Juno and funds for research support from AbbVie, AstraZeneca, BeiGene, Genentech, Juno, Loxo, MingSight, Oncternal, TG Therapeutics, and Verastem.

Staff Disclosure

Staff

Petra Cravens, PhD

Editorial Contributor

Petra Cravens, PhD, has no relevant conflicts of interest to report.

Terrence Fagan,

Associate Scientific Director

Terrence Fagan has no relevant conflicts of interest to report.

Jim Mortimer,

Product Director, Hematology/Oncology
Clinical Care Options, LLC

Jim Mortimer has disclosed that his spouse has ownership interest in AstraZeneca.

Kevin Obholz, PhD

Editorial Director, Hematology/Oncology

Kevin Obholz, PhD, has no relevant conflicts of interest to report.

Timothy A. Quill, PhD

Senior Managing Editor

Timothy A. Quill, PhD, has no relevant conflicts of interest to report.

Instructions for Credit

Accreditation

Joint Accreditation Statement

In support of improving patient care, Clinical Care Options, LLC (CCO) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Credit Designation

CCO designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Additional Information

Participation in this self-study activity should be completed in approximately 1.5 hours. To successfully complete this activity and receive credit, participants must follow these steps during the period from September 16, 2020, through September 15, 2021:

1. Register online at http://www.clinicaloptions.com.
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 65% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME/CE activities completed can be found on the "CME/CE Manager" page. There are no costs/fees for this activity.

Program Medium

This program has been made available online.

Goal

The goal of this activity is to improve the knowledge, confidence, and competence of learners to integrate BTK inhibitors into the treatment of patients with CLL.

Clinical Education Alliance Terms and Conditions

These Terms of Use ("Terms") apply to your use of the websites, mobile applications and other resources provided by Clinical Education Alliance LLC (“CEA”) and its affiliates (referred to collectively as "CEA," "us," "we" and "our") that are intended for use by healthcare professionals, which we refer to as the "CEA Network," including the personalized information and services that meet the needs and interests of users of the CEA Network such as medical news, reference content, clinical tools, applications, sponsored programs, advertising, email communications, continuing medical education, market research opportunities and discussion forums (collectively, the "Services"). You will always be able to view the most current version of these Terms by clicking on the Terms of Use link at the bottom of any page of a CEA Network property. Note that these Terms do not apply to our properties and services that display a link to different terms of use. In the event that we expand the CEA Network through our acquisition of another company and/or its properties, that company may operate its properties subject to its own terms of use accessible via a link on such properties until we integrate its practices with ours, at which point a link to these Terms will be displayed on its properties. By using the Services, you agree to these Terms, whether or not you are a registered member of the CEA Network. These Terms govern your use of the Services and create a binding legal agreement that we may enforce against you in the event of a violation. If you do not agree to all of these Terms of Use, do not use the Services!

We reserve the right to change these terms from time to time. The most current version may be viewed by clicking on the “Terms of Use” link at the bottom of designated pages on the Clinical Education Alliance Sites. Use of the Clinical Education Alliance Sites after the effective date constitutes acceptance of the amended Terms of Use. When you leave a CEA Web site and go to another Web site, different terms apply and CEA has no responsibility or liability for any content on those sites.

Clinical Education Alliance Content

The Clinical Education Alliance Sites incorporate information, including modules, capsules, journal articles, medical news, references, interactive case studies, other continuing education material, downloadable software applications, advertising, and other healthcare information, which is intended for adults who are licensed healthcare professionals. This information is not intended to serve as a substitute for the healthcare professional’s clinical judgment. If you are a consumer who chooses to read this professional-level information on Clinical Education Alliance Sites, you should not use or rely on that information as professional medical advice or use it to replace any relationship with your physician or other qualified healthcare professional or any information they may have provided to you. For medical issues or concerns, including decisions about medications and other treatments, consumers should always consult their physician or, in serious cases, seek immediate assistance from emergency personnel.

The Content on the Clinical Education Alliance Sites is developed or selected in accordance with our published Editorial Policies. However, users access and use this material at their own risk. It is the reader’s job to evaluate the accuracy of any information and results from interactive programs found on the Clinical Education Alliance Site. If you are a healthcare professional, you should rely on your professional judgment in evaluating any and all information and confirm the information contained on the Clinical Education Alliance Sites with other sources and reliable third parties before basing any treatment or advice on it. If you are a consumer, you should evaluate the information together with your physician or another qualified healthcare professional.

DISCLAIMERS AND LIMITATIONS OF LIABILITY

THE CONTENT, APPLICATIONS, SOFTWARE, AND ALL OTHER MATERIAL ON THE CLINICAL EDUCATION ALLIANCE SITES ARE PROVIDED “AS IS” AND WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT. ALL WARRANTIES, EXPRESS OR IMPLIED, ARE HEREBY DISCLAIMED. CLINICAL EDUCATION ALLIANCE SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, PHYSICAL HARM OR INJURIES, LOST REVENUES, OR LOST PROFITS, RESULTING FROM THE USE OR MISUSE OF THE CLINICAL EDUCATION ALLIANCE SITES, OR ANY INFORMATION, APPLICATIONS, MATERIALS, OR SOFTWARE THEREON, EVEN IF CLINICAL EDUCATION ALLIANCE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR FOR ANY CLAIM BY ANOTHER PARTY. CLINICAL EDUCATION ALLIANCE DOES NOT WARRANT THAT THIS SITE OR ANY APPLICATIONS OR SOFTWARE WILL BE FREE OF BUGS, INACCURACIES, OR ERRORS, NOR DOES CLINICAL EDUCATION ALLIANCE WARRANT THAT ANY SITE, SOFTWARE, OR APPLICATION IS FREE OF VIRUSES OR OTHER HARMFUL ELEMENTS.

A user’s use of the Clinical Education Alliance Sites, and any reliance on any materials, information, software, or applications, is at the user’s own risk. You agree that you hereby release Clinical Education Alliance and its affiliates, owners, respective directors, officers, employees, advertisers, authors, and contributors from any and all liability or obligations arising from the use of the Clinical Education Alliance Sites. A user’s sole remedy for any problem or concern is to exit the Web site or application. You agree that you will indemnify and hold Clinical Education Alliance harmless for any loss, damages, or liability suffered by Clinical Education Alliance as a result of your use of any Clinical Education Alliance Site or material, application, information, or software thereon or your submission of any material to Clinical Education Alliance. Clinical Education Alliance reserves the right to restrict or limit access to this Web site.

CEA Programs, Tools, and Databases

The Clinical Education Alliance Sites include interactive programs, clinical tools, and databases intended for the use of healthcare professionals. These materials are not intended as professional advice or recommendations of particular products. Physicians and other healthcare professionals who use our interactive programs, tools, or databases should exercise their own clinical judgment as to the results. Consumers who use the tools or databases do so at their own risk.

Individuals with any type of medical condition are specifically cautioned to seek professional medical advice before beginning any sort of health treatment. For medical concerns or issues, including decisions about medications and other treatments, users should always consult their physician or other qualified healthcare professional.

Ownership of Clinical Education Alliance Sites—Copyright and Trademarks

The entire contents and design of the Clinical Education Alliance Sites, including the software applications, tools, and databases, are protected under US and international copyright laws. These materials are owned by CEA or its affiliates or are used with permission of their owners or as otherwise authorized by law. All rights are reserved, worldwide. You may look at the Clinical Education Alliance Sites, download individual articles or applications to your personal computer or handheld device, and print a reasonable number of pages for your own personal reference. You must not remove any copyright notices from our materials. We reserve all our other rights. This means you may not sell, rewrite, or modify any content or other material found on any Clinical Education Alliance Site, redistribute it, put it on your own Web site, or use it for any commercial purpose without our prior written authorization.

The names of the CEA products and services are protected by trademark laws in the United States. Any use of our trademarks or service marks requires prior written approval from CEA.

You may link to a CEA Web site if your Web site offers products, services, or information of interest to the professional healthcare community. You are not allowed to link to the Clinical Education Alliance Sites if you post illegal, obscene, or offensive content or if the link is likely to have a negative impact on CEA’s reputation. Any other use, such as framing any part of a CEA Web site or incorporating any CEA content into another Web site, product, or application, requires advance written permission from Clinical Education Alliance. Clinical Education Alliance assumes no responsibility for any Web sites or materials that are linked to Clinical Education Alliance Sites or materials.

Software Products and Applications

Clinical Education Alliance makes some software and accompanying documentation available for downloading from our Web sites and/or from iTunes. These materials are protected by copyrights under US and international law and are owned by Clinical Education Alliance or companies that have licensed the software to us. We do not transfer any ownership rights in software or documentation to you when you download it from our Web site and/or directly from iTunes. You may use the software and accompanying documentation for their intended purpose. You are not authorized to further copy or distribute the software and accompanying documentation, nor may you attempt to recreate or reverse engineer our software or applications. In addition, some software available for downloading from our Web sites and/or from iTunes is subject to US export controls. By downloading or using such software, you are representing to us that your download of such software complies with these controls.

US Government End Users

If you are affiliated with the US government, please note that the software and documentation available on our Web sites and/or directly from iTunes are “commercial items,” as that term is defined in 48 C.F.R. 2.101 (October 1995), consisting of “commercial computer software” and “commercial computer software documentation,” as such terms are used in 48 C.F.R. 12.212 (September 1995). Consistent with 48 C.F.R. 12.212 and 48 C.F.R. 227.7202-1 through 227.7202-4 (June 1995), all US government end users acquire the software and documentation with only those rights set forth herein.

Social Media, Message Boards, and Forums

Clinical Education Alliance offers users the opportunity to engage in social media interactions with both experts and other users of the sites. As with other online social media, users must exercise sound judgment in both the information that they post and in how they assess the postings of other users. As such, users are expected to adhere to the social media recommendations made by the American Medical Association when utilizing the social media capabilities of CEA sites. In particular, users must be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments and must not post identifiable patient information on CEA sites. In social media interactions, users must maintain appropriate boundaries of the patient–physician/care provider relationship in accordance with professional ethical guidelines just as they would in any other context. Users acknowledge that privacy settings are not absolute and that once on the Internet, content posted by them may be copied by third parties and republished out of the control of Clinical Education Alliance. Thus, users should routinely monitor their own Internet presence to ensure that the personal information and content that they post and, to the extent possible, that is posted about them by others is accurate and appropriate.

Users are expected to refrain from submitting comments or messages that are defamatory, hateful, or obscene or that harass others. Users may not impersonate any other person or violate any other person’s or entity’s legal rights or submit falsified credentials or experiences. Users agree that they will not submit any materials that violate or infringe any copyrights, trademarks, patents, trade secret, or other intellectual property rights of any third party. Clinical Education Alliance retains all copyrights in the content posted by users to its sites. Clinical Education Alliance may adopt additional rules to govern use of social media, message boards or forums, to which users will be subject.

Copyright and Other Legal Violations

If you believe that any material on this Web site infringes your copyright, please notify us as follows, under the Digital Millennium Copyright Act (“DMCA”). To notify us, the DMCA requires that you: 1. Send an email notice to Clinical Education Alliance at customersupport@clinicaloptions.com. 2. Include the following information in your email: a. Identify the copyrighted work(s) you claim is infringed; b. Identify the material you claim is infringing the copyright(s) and give enough information for Clinical Education Alliance to locate that material; c. Include a physical or electronic signature of the copyright owner or a person authorized to act on the copyright owner’s behalf (the “Claimant”); d. Include the Claimant’s name, address, and telephone number(s); e. Include a statement that the Claimant has a good faith belief that use of the disputed material is not authorized by the copyright owner or his agent; and f. Include a statement, under penalty of perjury, that the information in the notification of copyright infringement is accurate and that the Claimant is the copyright owner or is authorized to act on behalf of the copyright owner.

If you believe any content or material on the Clinical Education Alliance Sites violates any laws, please notify customersupport@clinicaloptions.com. Please include details about your concerns and an email address for contacting you.

Governing Law

Clinical Education Alliance controls the Clinical Education Alliance Sites from its offices in the state of Virginia in the United States of America. The Clinical Education Alliance Sites can be accessed from any of the United States and from other countries worldwide. Since the laws of each state or country may differ, both you and Clinical Education Alliance agree that the laws of Virginia, without regard to conflicts of laws principles, will apply to all matters relating to use of the Clinical Education Alliance Sites and materials, including software and applications.

Clinical Education Alliance makes no representation that materials on these sites are appropriate or available for use in countries aside from the United States. Accessing the Clinical Education Alliance Sites from territories where their contents are illegal is prohibited. Those who choose to access these sites from other locations do so at their own risk and are responsible for compliance with any and all applicable local laws or regulations.

Acceptance Procedure

By downloading or accessing materials on the Clinical Education Alliance Sites and/or directly from iTunes or registering with us, you agree to all the terms and conditions in this agreement, including the Terms of Use and Privacy Policy. If you disagree with any of these Terms of Use or Privacy Policy, please refrain from using the Clinical Education Alliance Sites or materials.

Privacy Policy

Because we provide education for healthcare professionals, we pay special attention to privacy issues. The purpose of our Privacy Policy is to identify the information we may collect about you, describe the uses we may make of your information and the security measures we take to protect it, and discuss your options for controlling your information. You can review our Privacy Policy by clicking on the “Privacy Policy” link at the bottom of designated pages on the Clinical Education Alliance Sites.

Disputes

If you fail to comply with these terms, we have the right to suspend or eliminate your account and remove any information you have placed on our site, including your registration information. We may also take any legal action we think is appropriate. If there is any dispute between us concerning this agreement or your use of any Clinical Education Alliance Site or materials or applications, we both agree to submit the dispute to nonbinding mediation, followed by binding arbitration. Both the mediation and the arbitration will be governed under the rules of the American Arbitration Association, and the venue for the arbitration will be Virginia.

Questions or Concerns About Our Terms of Use

For questions or concerns about these Terms of Use, please send an email to customersupport@clinicaloptions.com

These terms of use were last updated in July 2021.

Chronic Lymphocytic Leukemia: New Horizons With BTK Inhibitors