Diagnosis: Acute Myeloid Leukemia (AML). A Journey

This past couple of weeks has been a busy time for us. George started his chemo infusions on Sept 25th and finished them up on Oct 3. He was also taking the oral chemo pill venetoclax. During this time, he had an echocardiogram and an electrocardiogram to clear him for the clinical trial. Because his hemoglobin got low during this time, he received units of blood on the 25th (2 units) and 28th of Sept and also on the 3rd of Oct.

He also had an x-ray done of his PICC line because it looks like it’s been slowly working its way out of his arm. A while back, the home health nurse snipped the stitch that was holding it in place because it was just too tight. So, now he has an appointment to go in on Tue, Oct 10 the have it replaced. But it looks like that’s the only day we will have to drive to Philadelphia next week! Yay! Unless…he needs an infusion of platelets, which he probably will. Hopefully they can do it the same day.

Anyway, we met with Dr. Lai yesterday to go over the timeline/calendar for the clinical trial. George will have one last office visit with Dr. Lai on Oct 17th, as well as have some pre-trial labs done and a bone marrow biopsy. Then on October 18, he will be admitted into the hospital.

On the 18th, he will begin lymphocyte depleting chemotherapy (LDC) for 3 days (18,19,20 Oct) and then receive his new manufactured cells on the 23rd. Then he will remain in the hospital for at least another two weeks so the team can monitor him for any side effects from the process and treat him immediately if anything arises, like an infection.

WHY DO THE CLINICAL TRIAL?

George was asked to participate in the trial because he has Acute Myeloid Leukemia (AML) that has failed prior treatment. A clinical trial is nobody’s first choice and not in the standard of care protocol. The goal, as I previously wrote, is to get George into a deep remission so he can then proceed to bone marrow transplant. The chemo regiments that had previously done the job of getting him below 5% blasts isn’t having the same effect. So, the hope is, as Dr. Lai said, that this treatment will be a bridge to transplant.

Again, this study tests the infusion of CART-38 cells in patients with AML. The researchers will take some of George’s own white blood cells, called T cells, and modify them to target his cancer cells or cells that help cancer grow. The modification is a genetic change, or gene transfer, to his normal T cells. The type of modified cells given in this study is called CART-38 cells.

Patients who are approved for CAR T-cell therapy will undergo the following treatment process:

• Collection: Patients undergo leukapheresis. During this process, white blood cells (including T cells) are collected from the patient.
• Modification: The team sends the collected cells to the manufacturing laboratory, where they are genetically modified to express chimeric antigen receptors (CARs) on their surface.
• Multiplication: The genetically modified T cells are grown in the lab, multiplying so they increase in number. The lab freezes the multiplied cells and ships them back to UPenn; this process takes about 2-3 weeks.
• Chemotherapy: Patients will receive conditioning chemotherapy a few days prior to their hospital admission for infusion. This therapy improves the ability of the infused CAR T cells to expand and multiply.
• Infusion and Inpatient Hospitalization: Patients are admitted to the hospital at UPEnn and the CAR T cells are infused back into their bloodstream in a single infusion, like a blood transfusion. Patients typically stay in the hospital for at least 2 weeks following infusion so the team can closely monitor them for potential side effects.
• Recovery: The risk/recovery period following CAR T-cell therapy is usually 2-3 months. During this period, patients must be monitored for side effects and treatment response, which can be severe. The patient must remain near the hospital for 30 days.

Being a clinical trial, the use of CART-38 cells is experimental and has not been approved by the Food and Drug Administration (FDA). This is the first study to test the infusion of CART-38 cells in patients! Both exciting and scary, right?

CART-38 cells target a tumor marker on AML cells called CD38. CD38 is a protein expressed on the surface of cancerous cells in patients with AML. By targeting these cells, CART-38 may help control AML. It is not a cure. The only curative measure for AML is a new immune system from a donor through a bone marrow transplant.

So, that’s the latest update. George is anxious to get on with the study so he can proceed to transplant, but nervous at the same time which is completely understandable. It’s comforting to know that CART therapy for other cancers HAS been approved by the FDA and is being used successfully. So, it’s not unchartered territory.

This may be too much information and repetitive, but I am not making this blog post only to inform the reader, but also to make a record for myself. I feel that TMI is better than not enough!

Until next time…..we thank you for your continued support!