CAPTIRALL _ Combination of an Anti-PD1 antibody with Tisagenlecleucel Reinfusion in children, adolescents and young adults with Acute Lymphoblastic Leukemia after loss of persistence

Conditions

children, adolescents and young adults with Acute Lymphoblastic Leukemia

Brief summary

Safety: absence of Limiting-toxicities between infusion and D28, Efficacy: evaluation at M3 after tisagenlecleucel reinfusion and defined by MRD negative CR AND B cell aplasia

Detailed description

• Incidence of B cell aplasia at 6 months, • Increase of B cell aplasia duration compared to the previous one observed after the first infusion of tisagenlecleucel (up to 24 months), • Disease best response, • Complete remission (at M1 M3 M6 M12 after reinfusion), • Minimal residual disease (at M1 M3 M6 M12 after reinfusion), • 1-year OS, • 1-year EFS, • Incidence of Grade 3 adverse up to 2 years events such as - nivolumab-related adverse events: myocarditis, pneumonitis, encephalitis - tisagenlecleucel reinfusion-related events, in particular CRS or ICANs or aGVH, prolonged cytopenias, • Incidence of Grade 3, 4 or 5 nivolumab-related adverse events up to 2 years: gut, liver, endocrine, stomatitis, rash or hematologic toxicity, • Incidence of GVHD up to one year, Long term efficacy: 2-year OS and EFS, To explore the PD1 PDL1 axis and its correlation with success or failure

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGKymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Safety: absence of Limiting-toxicities between infusion and D28, Efficacy: evaluation at M3 after tisagenlecleucel reinfusion and defined by MRD negative CR AND B cell aplasia	—

Secondary

Measure	Time frame
• Incidence of B cell aplasia at 6 months, • Increase of B cell aplasia duration compared to the previous one observed after the first infusion of tisagenlecleucel (up to 24 months), • Disease best response, • Complete remission (at M1 M3 M6 M12 after reinfusion), • Minimal residual disease (at M1 M3 M6 M12 after reinfusion), • 1-year OS, • 1-year EFS, • Incidence of Grade 3 adverse up to 2 years events such as - nivolumab-related adverse events: myocarditis, pneumonitis, encephalitis - tisagenlecleucel reinfusion-related events, in particular CRS or ICANs or aGVH, prolonged cytopenias, • Incidence of Grade 3, 4 or 5 nivolumab-related adverse events up to 2 years: gut, liver, endocrine, stomatitis, rash or hematologic toxicity, • Incidence of GVHD up to one year, Long term efficacy: 2-year OS and EFS, To explore the PD1 PDL1 axis and its correlation with success or failure	—

Measure

Time frame

• Incidence of B cell aplasia at 6 months, • Increase of B cell aplasia duration compared to the previous one observed after the first infusion of tisagenlecleucel (up to 24 months), • Disease best response, • Complete remission (at M1 M3 M6 M12 after reinfusion), • Minimal residual disease (at M1 M3 M6 M12 after reinfusion), • 1-year OS, • 1-year EFS, • Incidence of Grade 3 adverse up to 2 years events such as - nivolumab-related adverse events: myocarditis, pneumonitis, encephalitis - tisagenlecleucel reinfusion-related events, in particular CRS or ICANs or aGVH, prolonged cytopenias, • Incidence of Grade 3, 4 or 5 nivolumab-related adverse events up to 2 years: gut, liver, endocrine, stomatitis, rash or hematologic toxicity, • Incidence of GVHD up to one year, Long term efficacy: 2-year OS and EFS, To explore the PD1 PDL1 axis and its correlation with success or failure

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Countries

France

Outcome results

None listed