Myelodysplastic Syndromes Clinical Trial
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
Verified date | September 2023 |
Source | Bellicum Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 187 |
Est. completion date | April 14, 2023 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | Inclusion Criteria: - Signed written informed consent by the patient or the patient's guardian for children who are minors - Enrolled on BP-004 protocol, received BPX-501 infusion, completed or discontinued from the study, and are beyond Day +180. Exclusion Criteria: - Lack of parents'/guardian's informed consent for children who are minors - Loss of allograft prior to 6 months |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale Pediatrico Bambino Gesù | Rome |
Lead Sponsor | Collaborator |
---|---|
Bellicum Pharmaceuticals |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population | 1 and 2 years after rivogenlecleucel infusion | |
Primary | Incidence of Disease-free Survival | KM Parameter Estimates of disease-free survival (DFS) in the non-malignant subpopulation at 1 and 2 years in the Intent-to-Treat (ITT) Population | 1 and 2 years after rivogenlecleucel infusion | |
Primary | Relapse-free Survival | Kaplan-Meier Parameter Estimates of Relapse-free survival rate (number of patients survived without experiencing a recurrence) at the 1-year and 2-year timepoints in the Intent-to-Treat (ITT) Population in the malignant study arm (patients with a malignant reason for their transplant).
ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg |
1 and 2 years after rivogenlecleucel infusion |
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