Phase I II clinical trial on the safety and preliminary efficacy of donor derived anti leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation study rational and design Quiz

Emily is a 9-year-old female diagnosed with acute lymphoblastic leukemia (ALL) undergoing haploidentical hematopoietic stem cell transplantation (haplo-HCT). She is enrolled in the Leuk-CTL-001 trial and is scheduled to receive donor-derived anti-leukemia cytotoxic T lymphocytes (CTLs) infusion within 60 days post-transplant. Her medical history includes mild eczema, and she is currently on immunosuppressive therapy to prevent graft-versus-host disease (GVHD).

Question: As the clinical pharmacist, what is the most critical safety parameter to monitor closely following Emily’s infusion of donor-derived anti-leukemia CTLs?

Jacob is a 12-year-old boy with acute myeloid leukemia (AML) scheduled for haploidentical hematopoietic stem cell transplantation. His leukemia exhibits unfavorable cytogenetic abnormalities and measurable minimal residual disease (MRD). However, no cryopreserved leukemia blasts (LB) are available from his diagnostic samples. The transplant team is considering enrollment in the Leuk-CTL-001 trial.

Question: Based on the Leuk-CTL-001 trial design, what is the most appropriate next step regarding Jacob’s eligibility for donor-derived anti-leukemia CTL therapy?

Sophia is a 7-year-old female with high-risk acute lymphoblastic leukemia undergoing haploidentical HCT. She has successfully received her first infusion of donor-derived anti-leukemia CTLs 30 days post-transplant at a low dose. The clinical team is considering the next infusion and dose escalation strategy.

Question: According to the Leuk-CTL-001 trial design, what is the recommended timing and approach for subsequent donor-derived anti-leukemia CTL infusions in Sophia?