Clinical trial · Interventional
Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
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
NCT03733249CI-TRIAL-00069915terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Anemia, Aplastic | — | UNRESOLVED | — |
| Anemia, Sickle Cell | — | UNRESOLVED | — |
| Cytopenia | — | UNRESOLVED | — |
| Diamond Blackfan Anemia | — | UNRESOLVED | — |
| Fanconi Anemia | — | UNRESOLVED | — |
| Hemoglobinopathies | — | UNRESOLVED | — |
| Leukemia, Acute Myeloid (AML), Child | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rimiducid | Drug | — | UNRESOLVED |
| rivogenlecleucel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rimiducid and Rivogenlecleucel
- description
- Rimiducid: to treat uncontrolled GVHD in patients who have received rivogenlecleucel Rimiducid will be given at 0.4 mg/kg weight (intravenous infusion) No further rivogenlecleucel infusions are planned. Patients who received rivogenlecleucel in the BP-004 study will be evaluated for long-term safety and efficacy.
- interventionNames
- Drug: Rimiducid
- Biological: rivogenlecleucel
Primary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 1 and 2 years after rivogenlecleucel infusion
- description
- Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population
- measure
- Incidence of Disease-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.