A Phase 1 interventional study of Adult differentiated autologous T-cells in Leukemia and Lymphoma, sponsored by Sara V. Latorre. Completed at 2 sites in Spain. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Sara V. Latorre · Phase 1, Interventional, and Other
To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
This study's enrollment of 50 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.
Browse Leukemia studies →Sara V. Latorre is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z. Such cells will be administered in a single infusion intravenously at a total ARI-0001 cell dose of 0.5-10 x 106 / kg body weight.
Biological: Adult differentiated autologous T-cells
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
Procedure-related mortality (PRM)
Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event.
Time frame: Year 1
Procedure-related mortality (PRM)
Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event.
Time frame: Year 3
Assessment of toxicity
number of adverse events grade III-IV using CTC (common toxicity criteria)
Time frame: Month 3
Assessment of toxicity
number of adverse events grade III-IV using CTC (common toxicity criteria)
Time frame: Year 1
Response rate (overall and complete)
Defined differently for each disease: * On chronic lymphoid and acute lymphocytic leukemia, the usual criteria NCCN and IWCLL will be used. * On non-Hodgkin's lymphoma, the Lugano criteria will be used- * On patients with leukemia will be quantified the persistence of minimal residual disease, in bone marrow and peripheral blood, using multiparametric cytometry and new generation sequencing techniques.
Time frame: Month 3 and Year 1
Progression-free survival
Time lag between infusion of ARI-0001 and the progression of disease or death. Patients alive and in complete remission will be censored at the last follow-up
Time frame: Year 2 after procedure
Overall survival (OS) at 2 years
Time lag between the infusion of ARI-0001 and the death of the patient from any cause. Living patients will be censored at the the last follow-up.
Time frame: 3 years
In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid
Determined monthly during the first 6 months by flow cytometry and quantitative transgene PCR.
Time frame: months 1,2,3,4,5,6
In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid
Determined quarterly from month 6 until the 2 years after infusion, by flow cytometry and quantitative transgene PCR.
Time frame: months 9,12,15,18,21,24
Quality of life of included patients
Evaluated by a questionnaire completed by patients or their legal guardians
Time frame: Month 3, 6, 12
Toxicity assessment
defined as number of adverse events of any type occurring throughout the study using the common toxicity criteria
Time frame: Month 3 and year 1
Plan to share: No
Ran from Jun 2017 to primary completion in Sep 2022, 62 months.
Of 276 non-industry phase 1 interventional studies under Leukemia, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 80. This study's 62 months is above that.
Counting every sponsor, half of 452 studies reached it within 47 months; a quarter within 29 and three quarters within 72.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Sara V. Latorre