TerminatedPhase 1/2

Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study

Italy187 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range1 Month – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Overall Survival

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Incidence of Disease-free Survival

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Relapse-free Survival

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Trial details

NCT IDNCT03733249

SponsorBellicum Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-30

Results submitted2023-06-22

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials