SYFb382d2df2ce94ead98e170eeccd9a662Registry ID: 2024-515467-66-00|Active Not RecruitingPhase 2
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interventional
N/A
1 country
5
To evaluate the efficacy (response rate) of ARI-0001 cells in paediatric patients with CD19+ acute lymphoblastic leukaemia that is resistant or refractory to therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2024
Actual (reported)Complete response rate (complete remission [CR] rate plus CR rate with incomplete haematological recovery [CRi]), with undetectable measurable residual disease by multiparameter flow cytometry within day +100 after the infusion of ARI-0001 cells. In patients with isolated extramedullary disease, response evaluation will be done through morphology and flow cytometry of the cerebrospinal fluid (CSF) and/or imaging tests (PET-CT or MRI)
Key secondary endpoint: Event-free survival (EFS) at month 12
Duration of remission: defined as the time from achievement of CR or CRi (whichever occurs first) to relapse or death due to ALL
Relapse free survival (RFS) at 12 months
Overall survival at 12 months
Transplant and disease-free survival at 6 and 12 months
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
ETOPOSIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
METHYLPREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
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FLUDARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
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CYTARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
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CYCLOPHOSPHAMIDE
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
ETOPOSIDE
Named ingredient: Etoposide
View registry recordMETHYLPREDNISOLONE
Named ingredient: Methylprednisolone
View registry recordFLUDARABINE
Named ingredient: fludarabine
View registry recordCYTARABINE
Named ingredient: Cytarabine
View registry recordCYCLOPHOSPHAMIDE
Named ingredient: Cyclophosphamide
View registry recordALLOPURINOL
Named ingredient: Allopurinol
View registry recordTOCILIZUMAB
Named ingredient: tocilizumab
View registry recordHospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, 08950, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Clinical Trial Unit
First Submitted
July 10, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
Formulated product
ALLOPURINOL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
TOCILIZUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordContact the study team to confirm eligibility.
Hospital Infantil Universitario Nino Jesus
Madrid, 28009, Spain
University Hospital Virgen Del Rocio S.L.
Sevilla, 41013, Spain