This activity is the third in a series of four educational activities on treating relapsed/refractory Ph- acute lymphocytic leukemia. Dr. Ayman Qasrawi from the University of Kentucky Markey Cancer Center, discusses treatment options and outcomes. He introduces a case study highlighting the treatment decisions in a patient with relapsed Ph – ALL.

LEARNING OBJECTIVES

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

• Identify patients who could benefit from CD22-directed ADC therapy using current practice guideline recommendations

Faculty:

Ayman Qaswari, MD

Assistant Professor

Division of Hematology & BMT

University of Kentucky

Lexington, KY

Content Reviewers:

Kirsten Roblee, MHI, BSN, RN, OCN 

Administrative Nurse Manager, Oncology Infusion Services

Dublin Methodist Hospital & Grady Memorial Hospital

Ohio Health

Columbus, OH

METHOD OF PARTICIPATION/HOW TO RECEIVE CREDIT

Technical Requirements: http://www.francefoundation.co...

• There are no fees for participating in and receiving credit for this activity
• Review the activity objectives and CME/CE information
• Complete the CME/CE activity
• Complete the online posttest. A score of at least 80% is required to successfully complete this activity. The participant may take the test until successfully passed.
• Complete the CME/CE evaluation/attestation form. This form provides each participant with the opportunity to comment on how participating in the activity will affect their professional practice; the quality of the instructional process; the perception of enhanced professional effectiveness; the perception of commercial bias; and his/her views on future educational needs.

Credit documentation/reporting:

• If you are requesting AMA PRA Category 1 Credits™ or a certificate of participation—your CME/CE certificate will be available for download

ACCREDITED PROVIDER 

This activity is provided by The France Foundation. This activity was produced in collaboration with American Society for Transplantation and Cellular Therapy.

TARGET AUDIENCE

The target audience for this initiative includes hematology/oncology physicians and other members of the multidisciplinary cancer care team involved in the management of patients with acute lymphocytic leukemia.

STATEMENT OF NEED

Acute lymphocytic leukemia (ALL) is a heterogeneous malignancy of B or T lymphoblasts characterized by uncontrolled proliferation of abnormal, immature lymphocytes and their progenitors, which ultimately leads to crowding of bone marrow elements and other lymphoid organs.[i] While complete remission has improved over the past decades, almost 50% of adult patients will relapse.[ii] Prognosis for patients with relapsed or refractory (R/R) ALL is poor.[iii]

A number of treatments have been approved for and are in use for ALL, including chemotherapy, radiotherapy, and targeted therapy. Antibody-drug conjugate therapy directed against CD22 with inotuzumab ozogamicin (InO) has been shown in trials to be an effective tool to manage R/R Philadelphia chromosome positive or negative B-cell ALL, but it can be associated with venoocclusive disease (VOD), particularly manifesting in the liver as sinusoidal obstruction syndrome.[iv] The risk of VOD can be higher after hematopoietic stem cell transplantation (HSCT), particularly after certain conditioning regimens, but it is also possible without HSCT.⁴

Given that InO is effective, it is important that clinicians have the confidence to use it. Confidence can be improved with education, so clinicians are more familiar with this therapy, its place in guidelines, its adverse events, and how to manage them.

ACCREDITATION STATEMENT  

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The France Foundation and the American Society for Transplantation and Cellular Therapy. The France Foundation is accredited by the ACCME to provide continuing medical education for physicians.

CREDIT DESIGNATION

Physicians

The France Foundation designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses

Nurses who are certified by the American Nurses Credentialing Center (ANCC) may utilize activities that are certified by ACCME-accredited providers toward their requirement for certification renewal by the ANCC. A certificate of attendance will be provided by The France Foundation, an ACCME accredited provider.

DISCLOSURE POLICY

In accordance with the ACCME Standards for Commercial Support, The France Foundation (TFF) and American Society for Transplantation and Cellular Therapy (ASTCT) require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF and ASTCT resolve all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all their educational programs.

Furthermore, TFF and ASTCT seek to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF and ASTCT are committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

Disclosures

The following financial relationships have been disclosed:

DISCLOSURE OF UNLABELED USE

TFF and ASTCT require CME faculty (speakers) to disclose when products or procedures being discussed are off label, unlabeled, experimental and/or investigational, and any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration approved labeling.

This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF and ASTCT do not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information.

COMMERCIAL SUPPORT ACKNOWLEDGMENT

This activity is supported by an educational grant from Pfizer.

DISCLAIMER

The France Foundation (TFF) and the American Society for Transplantation and Cellular Therapy (ASTCT) present this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. TFF, ASTCT, and the commercial supporter(s) assume no liability for the information herein.

COPYRIGHT INFORMATION 

 Copyright © 2022 The France Foundation and The American Society for Transplantation and Cellular Therapy. Any unauthorized use of any materials on the site may violate copyright, trademark, and other laws. You may view, copy, and download information or software ("Materials") found on the Site subject to the following terms, conditions, and exceptions:

• The materials are to be used solely for personal, noncommercial, informational, and educational purposes. The materials are not to be modified. They are to be distributed in the format provided with the source clearly identified. The copyright information or other proprietary notices may not be removed, changed, or altered.

• Materials may not be published, uploaded, posted, or transmitted (other than as set forth herein) without The France Foundation's prior written permission

PRIVACY POLICY

The France Foundation protects the privacy of personal and other information regarding participants and educational collaborators. The France Foundation will not release personally identifiable information to a third party without the individual's consent, except when such information is required for reporting purposes to the ACCME. The France Foundation maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse, or alteration of information that we have collected from you. Additional information regarding The France Foundation’s Privacy Policy can be viewed at http://www.francefoundation.co.... 

CONTACT INFORMATION

If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or info@francefoundation.com.

 REFERENCES:

[i] Puckett Y, Chan O. Acute lymphocytic leukemia. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 29, 2021. https://pubmed.ncbi.nlm.nih.gov/29083572

[ii] Relapse in Acute Lymphoblastic Leukaemia (ALL). Leukemia Care. 2019. Accessed September 13, 2021. https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Lymphoblastic-Leukaemia-ALL-Web-Version.pdf

[iii] DeAngelo DJ, Advani AS, Marks DI, et al. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020;10(8):81. https://pubmed.ncbi.nlm.nih.gov/32769965

[iv] Kebriaei P, Cutler C, de Lima M, et al. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018;53(4):449-456. https://pubmed.ncbi.nlm.nih.gov/29330398