Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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3 October 2023 |
Main ID: |
NCT03733249 |
Date of registration:
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02/11/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
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Scientific title:
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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 aß+T Cells in Pediatric Patients Affected by Hematological Disorders |
Date of first enrolment:
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January 2017 |
Target sample size:
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187 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03733249 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Italy
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Saudi Arabia
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United Kingdom
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Contacts
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Name:
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Bellicum Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Bellicum Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Month
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leukemia, Acute Myeloid (AML), Child
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Myelodysplastic Syndromes
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Cytopenia
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Hemoglobinopathies
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Thalassemia
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Acute Lymphoblastic Leukemia
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Diamond Blackfan Anemia
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Anemia, Sickle Cell
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Lymphoma, Non-Hodgkin
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Anemia, Aplastic
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Fanconi Anemia
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Primary Immunodeficiency
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Intervention(s)
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Biological: rivogenlecleucel
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Drug: Rimiducid
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Primary Outcome(s)
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Incidence of Disease-free Survival
[Time Frame: 1 and 2 years after rivogenlecleucel infusion]
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Relapse-free Survival
[Time Frame: 1 and 2 years after rivogenlecleucel infusion]
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Overall Survival
[Time Frame: 1 and 2 years after rivogenlecleucel infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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