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Clinical Trials Awareness
Access to a clinical trial means more energy to dance and sing like a rock star
Diagnosis: B Cell Precursor Acute Lymphoblastic Leukemia
Age at Diagnosis: 5
Clinical Trial: Blinatumomab
It was the beginning of the pandemic and Abigale’s family was trying to make the best of the spring weather, going out for daily walks. Abigale found even the shortest of walks exhausting, complained of headaches, and said that her heart hurt. Her family called the Newfoundland health line and was told it was common in young children, but her parents felt it was something else. One day after a very short walk, Abigale told her parents she couldn’t see colour or out of her right eye and asked to take a nap. When her parents checked on her, she became hysterical and could not be calmed. That was when Abigale’s Mom and Dad, Staci and Artur, took their daughter to the local emergency. After a lot of bloodwork and tests, Abi was diagnosed with B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) on May 11, 2020.
The current and most effective treatment at the time of a diagnosis is called the “standard of care”. For pediatric cancer, when a new treatment has proven itself to be more effective than the standard treatment through a clinical trial, the new treatment becomes the current standard of care. Standard of care is considered to be the best course of treatment for the cancer at the time.
In a previous clinical trial, blinatumomab established itself as an effective treatment for relapsed and refractory childhood BCP-ALL. Blinatumomab is a monoclonal antibody that helps the immune system identify cancer cells and selectively destroy them. Blinatumomab showed improved disease-free survival, superior overall survival, reduced side-effects, and an improved ability for patients to achieve minimal residual disease (MRD) negative status, which improves pediatric patient outcomes with allogenic hematopoietic stem cell transplant (HSCT), part of the recommended treatment for BCP-ALL. The results of this early phase clinical trial established a new standard of care for first relapse/refractory childhood BCP-ALL.
Abi’s Mom and Dad were told good things about blinatumomab and made the decision to enroll Abi on a new Children’s Oncology Group (COG) clinical trial which introduces two rounds of blinatumomab into standard treatment for newly diagnosed BCP-ALL.
Abigale’s family weren’t sure if she would qualify to receive blinatumomab, as she had to get through important pre-treatment phases first. Abigale received a block of chemotherapy called “consolidation” in hopes of reaching MRD negative status. Treatment involves repeating cycles of the same or similar drugs used to bring about the remission.
During this time, Staci said that Abi was not herself – she was nauseous, vomiting, and could not eat. She was weaker and would often lose her footing causing her to trip. After consolidation, Abi had a tiny amount of disease in her bones, which meant she would receive blinatumomab beginning in July 2020. The hope was that blinatumomab would help Abi achieve a negative MRD status before moving onto the next steps of her treatment.
Abi was the second child at her home hospital to receive blinatumomab and was the first to be able to go home with the pump and not have to be admitted. Blinatumomab is given by continuous infusion for a total of four weeks (28 days). For many children, they are able to receive blinatumomab by carrying around a small portable pump in a backpack and do not have to stay in hospital. Abigale had a small reaction the first time she received blinatumomab, she spiked a fever and had some vomiting. However, after that first isolated reaction, she did very well on it.
Even though Abi carried the backpack everywhere, she was full of energy and proud to show her backpack off. Her blinatumomab backpack didn’t stop her from jumping and running everywhere. She also didn’t have any nausea or vomiting like with chemotherapy, which meant that she didn’t have any trouble eating. Staci described being on blinatumomab as “smooth sailing”. The biggest difficulty she experienced during treatment was that her skin reacted poorly to the bandages over her port and the team has had to use hypoallergenic dressings instead.
Abigale recently started her second round of blinatumomab and this time she had no reaction or fever. She’s feeling very well, has returned to in-person school, and has energy to dance and sing round the house. She loves animals, especially horses, and she loves to colour and make pictures for her family and friends.
Blinatumomab is a drug that is changing the stories for children and adolescents with BCP-ALL in a positive way. Abigale’s family has said if their results help someone else, it will be wonderful. If it takes away some treatment and side effects for children who are diagnosed with BCP-ALL in the future, that will be the benefit. Her tentative treatment end date is July 2022, they are hoping to enter maintenance in January 2021.
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