Signify Health partners on decentralized trials for children’s cancer

The Children’s Oncology Group (COG), a global organization aimed at childhood and adolescent cancer research, is joining with Signify Health (a platform leveraging various solutions for trial teams and patients) to facilitate trial participation for pediatric patients via at-home clinical services.

Pediatric patients taking part in COG Study AALL1731, a trial involving a potential therapy to treat B-cell acute lymphoblastic leukemia (B-ALL), as a result of the collaboration, will have more options to receive treatment at home. Typically studies involving infusion therapies at home are challenging because they require a credentialed provider to administer and because home health agencies are unable to bill insurance for investigational therapies.

Outsourcing-Pharma talked to two key players in the collaboration about what it involves, and how it might benefit sites, sponsors, and patients:

• Mignon Loh, chair of the COG ALL Committee
• Marc Rothman, chief medical officer of Signify Health

OSP: Could you please share the ‘elevator presentation’ of COG and the important work you’ve done since you opened your doors?​

ML: COG, a National Cancer Institute (NCI)-supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer.

Because childhood cancer is thankfully rare, these 229 institutions have come together to organize and coordinate clinical trials that will enroll enough patients to answer important questions about therapies that are significant.

OSP: How did Signify come to partner with COG?​

MR: We were introduced to COG through a life sciences company that was aware of COG’s great work and their interest in finding a partner to help them make in-home nursing services available as an option to patients. Once we began talking, we saw some natural synergies that made this opportunity a mutual fit -- and we are delighted to now be working with COG and the investigator teams at study sites.

ML: It is hoped that Signify Health’s clinical support services will help patients initiate investigational and approved therapies faster, improve their adherence to the study protocols, and provide a better overall experience for patients and their families.

OSP: Could you discuss some of the ways in which childhood and adolescent patients (and the cancers that they deal with) are uniquely challenging, compared to adult patients and their cancers?​

ML: The cancers that pediatric and adolescent patients suffer from are biologically different from the common forms that adults suffer from, and so the therapies are quite different and frequently more intensive.

Ensuring that patients are compliant with medications whether they are oral or IV is clearly key to improved survival. In addition, given that the whole family is affected by a child’s diagnosis, anything that allows a patient to stay at home for more of their treatment means fewer disruptions to family life and the possibility of having parents continue to work.

MR: Today’s pediatric cancer treatments, although often effective, can be harsh on small, growing bodies -- and the emotional impacts can be just as consequential. The intensity of treatment and clinical trials is often scary, overwhelming, and simply too much for a young child to understand and tolerate.

Until now, pediatric oncology clinical trials have been limited to site-based treatment, which creates barriers for many families. The inability to have an outpatient solution places a significant emotional and financial burden on families, often leading to low enrollment and high dropout rates.

OSP: Could you please tell us about AALL1731 and the experimental therapy at the center of the study?​

ML: AALL1731 (NCT03914625) is sponsored by the NCI under a Cooperative Research and Development Agreement (CRADA) with Amgen, and is currently open at 195 U.S. COG sites. The in-home infusion service is for the patients assigned to receive the experimental agent blinatumomab on AALL1731 who are unable to access outpatient pumps and homecare. Amgen has provided funding to NCI under the CRADA to support more pediatric patients to receive blinatumomab at home.

Blinatumomab is a BiTE molecule, which is a bi-specific T cell engaging (thus BiTE) molecule that brings the patient’s own T cells close to the patient’s CD19 positive leukemia cells and marks them for degradation. But it has a very short half-life and thus has to be delivered intravenously for 28 days, 24 hours per day.

OSP: How does designing this as an at-home trial benefit the patients, their families, and the study team/sponsor?​

MR: In-home clinical services allow more children to spend time at home and improve the patients’ overall experience by allowing them to receive treatment in a place where they feel comfortable and safe. Many clinical trials require lengthy hospital stays; without in-home treatment, the AALL1731 B-ALL clinical trial would require patients to spend between 60 to 90 days in the hospital.

Challenges with transportation and lack of reliable dependent care are examples of the social factors that can make participating in a clinical trial difficult for patients and their families. By providing in-home clinical service options and thus decentralizing some aspects of the clinical trial, it becomes easier for larger, more diverse populations to participate.

OSP: What is Signify Health’s role in this trial?​

ML: Signify Health is activating its national network of 9,000 credentialed clinicians to provide in-home infusion pumps and infusion bag changes to pediatric patients who have requested the in-home alternative. Signify Health clinicians will document patient metrics in real-time and be on call for the first 24 hours after a bag change to address any potential pump malfunctions.

OSP: Anything to add?​

MR: The cancer being studied in this trial, acute lymphoblastic leukemia, is the most prevalent and aggressive childhood cancer, representing 25% of diagnoses in children younger than 15 years old and is a leading disease-related cause of death in this age group. If we can make a difference with this in-home delivery option for even one child with this disease, it will have all been worth it.

As a physician whose career has been focused on vulnerable populations and home-based care, I’m incredibly proud of the work Signify Health is doing for pediatric cancer patients, helping to keep children on their study protocols, supporting parents and families at home, and collaborating with the amazing leadership at COG.

ML: COG physicians are keen to partner with pharmaceutical companies to bring new therapies to children and adolescents with cancer as quickly as possible. Having additional relationships with companies like Signify Health and others make it realistic to offer unique medications and advance our treatments.