Patients (male or female) ≥18 years old with R/R AML that expresses CD19 by Flow-cytometry
Conditions
Brief summary
Number of patients deceased without progression at one month after CAR T-cell infusion. Non-progression mortality (NPM). NPM is defined as death occurred in patients without evidence of AML progression. Absence of response, progression or relapse of AML define progression status
Detailed description
Number of patients with manufacturing failure and out of specification (OOS) deviation, Duration of CAR-T cell persistence in blood after infusion evaluated by flow-cytometry and PCR, Number of patients with overall response at one-month, Response duration, and number of patients alive at 3, 6 and 12 months, Number of patients alive without relapse at 3, 6 and 12 months, Number of deaths without progression at 3, 6 and 12 months, Number of patients with complete remission (CR) at 1 and 3 months
Interventions
DRUGMB-CART19.1
DRUGCYCLOPHOSPHAMIDE SANDOZ 500 mg
Sponsors
Centre Hospitalier Universitaire De Lille
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients deceased without progression at one month after CAR T-cell infusion. Non-progression mortality (NPM). NPM is defined as death occurred in patients without evidence of AML progression. Absence of response, progression or relapse of AML define progression status | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with manufacturing failure and out of specification (OOS) deviation, Duration of CAR-T cell persistence in blood after infusion evaluated by flow-cytometry and PCR, Number of patients with overall response at one-month, Response duration, and number of patients alive at 3, 6 and 12 months, Number of patients alive without relapse at 3, 6 and 12 months, Number of deaths without progression at 3, 6 and 12 months, Number of patients with complete remission (CR) at 1 and 3 months | — |
Countries
France
Outcome results
None listed