The INFLUENCE Trial: Improving EveNt Free Survival by Optimizing FLUdarabine Exposure during LymphodepletioN for CAR T CEll Therapy: a randomized, multi-center study of children and young adults with B-cell acute lymphoblastic leukemia

Conditions

B-cell Acute Lymphoblastic Leukemia

Brief summary

EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia <6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause

Detailed description

Death from any cause from the day of randomization., Non-response at 28 days, Cumulative incidence of relapse is defined as time from CAR T cell infusion until disease relapse in patients with a morphological complete response on day 28, Cumulative incidence of initiation of anti-leukemic therapy during the first two years after CAR T cell infusion, Type, incidence, severity, seriousness and relationship of CRS, ICANS, IEC-HS, cytopenia day 28 – day 180 (grade 3-4), and infectious adverse events (grade ≥3) during the first 180 days after CAR T cell infusion, Duration of B-cell aplasia and CAR T cell numbers from the day of CAR T cell infusion until 1 year, Duration of B-cell aplasia in the bone marrow from the day of CAR T cell infusion until 6 months after CAR T cell infusion, Definition of accuracy of fludarabine therapeutic drug monitoring (percentage of patients within the target of 18 mg*h/L, range 17.5-18.5 mg*h/L), Patient-reported outcome measures

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Interventions

DRUGFludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia <6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause	—

Secondary

Measure	Time frame
Death from any cause from the day of randomization., Non-response at 28 days, Cumulative incidence of relapse is defined as time from CAR T cell infusion until disease relapse in patients with a morphological complete response on day 28, Cumulative incidence of initiation of anti-leukemic therapy during the first two years after CAR T cell infusion, Type, incidence, severity, seriousness and relationship of CRS, ICANS, IEC-HS, cytopenia day 28 – day 180 (grade 3-4), and infectious adverse events (grade ≥3) during the first 180 days after CAR T cell infusion, Duration of B-cell aplasia and CAR T cell numbers from the day of CAR T cell infusion until 1 year, Duration of B-cell aplasia in the bone marrow from the day of CAR T cell infusion until 6 months after CAR T cell infusion, Definition of accuracy of fludarabine therapeutic drug monitoring (percentage of patients within the target of 18 mgh/L, range 17.5-18.5 mgh/L), Patient-reported outcome measures	—

Measure

Time frame

Death from any cause from the day of randomization., Non-response at 28 days, Cumulative incidence of relapse is defined as time from CAR T cell infusion until disease relapse in patients with a morphological complete response on day 28, Cumulative incidence of initiation of anti-leukemic therapy during the first two years after CAR T cell infusion, Type, incidence, severity, seriousness and relationship of CRS, ICANS, IEC-HS, cytopenia day 28 – day 180 (grade 3-4), and infectious adverse events (grade ≥3) during the first 180 days after CAR T cell infusion, Duration of B-cell aplasia and CAR T cell numbers from the day of CAR T cell infusion until 1 year, Duration of B-cell aplasia in the bone marrow from the day of CAR T cell infusion until 6 months after CAR T cell infusion, Definition of accuracy of fludarabine therapeutic drug monitoring (percentage of patients within the target of 18 mg*h/L, range 17.5-18.5 mg*h/L), Patient-reported outcome measures

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Outcome results

None listed