A Phase 1/2 interventional study of Rimiducid and rivogenlecleucel in Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child and Lymphoma, Non-Hodgkin, sponsored by Bellicum Pharmaceuticals. Terminated at 1 site in Italy. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Bellicum Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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.
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.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's enrollment of 187 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Bellicum Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Rimiducid · Biological: rivogenlecleucel
Rimiducid is administered to treat chronic graft versus host disease
Also known as: AP1903
donor T-cells modified with iCasp safety switch
Also known as: BPX-501
Overall Survival
Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population
Time frame: 1 and 2 years after rivogenlecleucel infusion
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
Time frame: 1 and 2 years after rivogenlecleucel infusion
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
Time frame: 1 and 2 years after rivogenlecleucel infusion
Study BP-404 was the long-term follow-up for patients enrolled in the BP-004 study at the Italian site as well as patients in Saudi Arabia (patients enrolled and treated in the UK who moved back after hematopoietic stem cell transplantation. The below participant flow information pertains to all patients in the BP-004 study (NCT02065869)
| Milestone | Rimiducid and Rivogenlecleucel |
|---|---|
| Started | 184 |
| Patients receiving rivogenlecleucel (bpx-501 safety population) | 171 |
| Intent-to-treat population | 142 |
| Patients receiving at least 1 dose of rimiducid | 16 |
| Completed | 149 |
| Not completed | 35 |
| Withdrew: Death | 7 |
| Withdrew: Disease relapse | 16 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: No rivogenlecleucel cells infused (non-evaluable) | 7 |
| Withdrew: Withdrawal by subject | 1 |
Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population
| Participants | Malignant | Non-malignant |
|---|---|---|
| 1 Year — Event Occurred | 8 | 3 |
| 1 Year — Censored | 3 | 8 |
| 1 Year — At Risk [Defined as: Total participants - (Event Occurred + Censored)] | 51 | 69 |
| 2 Years — Event Occurred | 8 | 4 |
| 2 Years — Censored | 4 | 13 |
| 2 Years — At Risk [Defined as: Total participants - (Event Occurred + Censored)] | 50 | 63 |
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
| Participants | Non-malignant |
|---|---|
| 1 Year — Event occurred | 4 |
| 1 Year — Censored | 7 |
| 1 Year — At Risk [defined as: Total participants - (Event occurred + Censored)] | 69 |
| 2 Years — Event occurred | 5 |
| 2 Years — Censored | 12 |
| 2 Years — At Risk [defined as: Total participants - (Event occurred + Censored)] | 63 |
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
| Participants | Malignant |
|---|---|
| 1 Year — Event Occurred | 12 |
| 1 Year — Censored | 0 |
| 1 Year — At Risk | 50 |
| 2 Years — Event Occurred | 13 |
| 2 Years — Censored | 1 |
| 2 Years — At Risk | 48 |
Collected over BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rivogenlecleucel (BPX-501) Safety Population | 7/171 (4.1%) | 52/171 (30.4%) | 140/171 (81.9%) |
| Rimiducid Safety Population | 0/16 (0%) | 7/16 (43.8%) | 9/16 (56.3%) |
| Event | Rivogenlecleucel (BPX-501) Safety Population | Rimiducid Safety Population |
|---|---|---|
| Acute graft versus host diseaseImmune system disorders | 4/171 | 2/16 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/171 | 1/16 |
| Parotid gland enlargementGastrointestinal disorders | 1/171 | 1/16 |
| SepsisInfections and infestations | 1/171 | 1/16 |
| Septic shockInfections and infestations | 1/171 | 1/16 |
| Staphylococcal bacteraemiaInfections and infestations | 1/171 | 1/16 |
| Central nervous system lesionNervous system disorders | 1/171 | 1/16 |
| EncephalopathyNervous system disorders | 1/171 | 1/16 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 1/171 | 1/16 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 1/171 | 1/16 |
| Event | Rivogenlecleucel (BPX-501) Safety Population | Rimiducid Safety Population |
|---|---|---|
| Acute graft versus host diseaseImmune system disorders | 48/171 | 3/16 |
| Cytomegalovirus infectionInfections and infestations | 34/171 | 0/16 |
| PyrexiaGeneral disorders | 33/171 | 0/16 |
| RashSkin and subcutaneous tissue disorders | 21/171 | 0/16 |
| DiarrheaGastrointestinal disorders | 20/171 | 0/16 |
| VomitingGastrointestinal disorders | 20/171 | 0/16 |
| PruritusSkin and subcutaneous tissue disorders | 12/171 | 0/16 |
| Adenovirus infectionInfections and infestations | 11/171 | 0/16 |
| Chronic graft versus host diseaseImmune system disorders | 5/171 | 1/16 |
| SepsisInfections and infestations | 1/171 | 1/16 |
HSCT safety population: All enrolled patients who received hematopoietic stem cell transplantation
| Age, Continuous(years) | Rimiducid and Rivogenlecleucel |
|---|---|
| Median | 5.8 (0.1 to 18.1) |
| Age, Customized(Participants) | Rimiducid and Rivogenlecleucel |
|---|---|
| < 2 years | 43 |
| 2 to < 12 years | 105 |
| 12 to ≤ 18 years | 35 |
| 18 to ≤ 26 years | 1 |
| Sex: Female, Male(Participants) | Rimiducid and Rivogenlecleucel |
|---|---|
| Female | 83 |
| Male | 101 |
| Ethnicity (NIH/OMB)(Participants) | Rimiducid and Rivogenlecleucel |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 176 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Rimiducid and Rivogenlecleucel |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 162 |
| More than one race | 1 |
| Unknown or Not Reported | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivogenlecleucel
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Bellicum Pharmaceuticals