Trial · NCT03733249

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

NCT03733249, Phase 1, Phase 2, Terminated, Bellicum Pharmaceuticals; results first posted 2023-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study. Trials, record NCT03733249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03733249

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
NCT number: NCT03733249
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 187 participants, actual
Lead sponsor: Bellicum Pharmaceuticals
Conditions: Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Primary Immunodeficiency, Anemia, Aplastic, Hemoglobinopathies, Cytopenia, Fanconi Anemia, Diamond Blackfan Anemia, Thalassemia, Anemia, Sickle Cell
Interventions: Rimiducid, rivogenlecleucel
First posted: 2018-11-07
Last updated: 2023-09-26
Results first posted: 2023-09-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	1 and 2 years after rivogenlecleucel infusion	Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population
Primary	Incidence of Disease-free Survival	1 and 2 years after rivogenlecleucel infusion	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
Primary	Relapse-free Survival	1 and 2 years after rivogenlecleucel infusion	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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	1 and 2 years after rivogenlecleucel infusion	ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg~Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Disease-free Survival	1 and 2 years after rivogenlecleucel infusion	ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg~Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Relapse-free Survival	1 and 2 years after rivogenlecleucel infusion	ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg~Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overall Survival	Malignant	1 Year / Event Occurred	8	Participants
Overall Survival	Non-malignant	1 Year / Event Occurred	3	Participants
Overall Survival	Malignant	1 Year / Censored	3	Participants
Overall Survival	Non-malignant	1 Year / Censored	8	Participants
Overall Survival	Malignant	1 Year / At Risk [Defined as: Total participants - (Event Occurred + Censored)]	51	Participants
Overall Survival	Non-malignant	1 Year / At Risk [Defined as: Total participants - (Event Occurred + Censored)]	69	Participants
Overall Survival	Malignant	2 Years / Event Occurred	8	Participants
Overall Survival	Non-malignant	2 Years / Event Occurred	4	Participants
Overall Survival	Malignant	2 Years / Censored	4	Participants
Overall Survival	Non-malignant	2 Years / Censored	13	Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rimiducid and Rivogenlecleucel	184
Overall Study	Patients Receiving Rivogenlecleucel (BPX-501 Safety Population)	Rimiducid and Rivogenlecleucel	171
Overall Study	Intent-to-Treat Population	Rimiducid and Rivogenlecleucel	142
Overall Study	Patients Receiving at Least 1 Dose of Rimiducid	Rimiducid and Rivogenlecleucel	16
Overall Study	COMPLETED	Rimiducid and Rivogenlecleucel	149
Overall Study	NOT COMPLETED	Rimiducid and Rivogenlecleucel	35

Source ClinicalTrials.gov

Adverse events158

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cytomegalovirus infection	Infections and infestations	Rivogenlecleucel (BPX-501) Safety Population	34	171
other	Cytomegalovirus infection	Infections and infestations	Rimiducid Safety Population	0	16
other	Adenovirus infection	Infections and infestations	Rivogenlecleucel (BPX-501) Safety Population	11	171
other	Adenovirus infection	Infections and infestations	Rimiducid Safety Population	0	16
other	Human herpesvirus 6 infection	Infections and infestations	Rivogenlecleucel (BPX-501) Safety Population	9	171
other	Human herpesvirus 6 infection	Infections and infestations	Rimiducid Safety Population	0	16
other	Acute graft versus host disease	Immune system disorders	Rivogenlecleucel (BPX-501) Safety Population	48	171
other	Acute graft versus host disease	Immune system disorders	Rimiducid Safety Population	3	16
other	Rash	Skin and subcutaneous tissue disorders	Rivogenlecleucel (BPX-501) Safety Population	21	171
other	Rash	Skin and subcutaneous tissue disorders	Rimiducid Safety Population	0	16

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rivogenlecleucel (BPX-501) Safety Population	7	171
Total, all-cause mortality	Rimiducid Safety Population	0	16
Total, other adverse events	Rivogenlecleucel (BPX-501) Safety Population	140	171
Total, other adverse events	Rimiducid Safety Population	9	16
Total, serious adverse events	Rivogenlecleucel (BPX-501) Safety Population	52	171
Total, serious adverse events	Rimiducid Safety Population	7	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rivogenlecleucel (BPX-501) Safety Population vs Rimiducid Safety Population: deaths from any cause	Trial comparisons
Rivogenlecleucel (BPX-501) Safety Population vs Rimiducid Safety Population: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT03733249/results?page=2

API reference For AI assistants