clinical trial · NCT03733249
Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
Acute Lymphoblastic LeukemiaLeukemia, Acute Myeloid (AML), ChildLymphoma, Non-HodgkinMyelodysplastic SyndromesPrimary ImmunodeficiencyAnemia, AplasticHemoglobinopathiesCytopeniaRimiducidrivogenlecleucel
brief summary
This is a long-term follow up study evaluating the safety of BPX-501 T cells (rivogenlecleucel) and infused in pediatric patients previously enrolled on the BP-004 study.
started
Jan 1, 2017
primary completion
Jun 30, 2020
completion
Apr 14, 2023
last updated
Sep 26, 2023
detailed description
Subjects enrolled on the BP-004 study who have completed or discontinued from the study, and are beyond Day 180 will be requested to enroll on this long-term follow up protocol. Long term follow up for gene therapy clinical and safety endpoints will continue up to 15 years.
official title
Follow-up of Phase 1/2 Study of CaspaCIDe T Cells (BPX-501) From an HLA-partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol