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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03733249
Other study ID # BP-404
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2017
Est. completion date April 14, 2023

Study information

Verified date September 2023
Source Bellicum Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Rimiducid
Rimiducid is administered to treat chronic graft versus host disease
Biological:
rivogenlecleucel
donor T-cells modified with iCasp safety switch

Locations

Country Name City State
Italy IRCCS Ospedale Pediatrico Bambino Gesù Rome

Sponsors (1)

Lead Sponsor Collaborator
Bellicum Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

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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