This is an open-label, multicenter two-arm study of Isatuximab in subjects with R/R or MRD-positive CD38 positive T-cell ALL who are at least 18 years of age. Two cohorts will be included in this study: In cohort 1 subjects with relapsed or primary refractory T-ALL will be treated with chemotherapy in combination with Isatuximab. In cohort 2 subjects with molecular failure or relapse (MRD positive) will be treated with Isatuximab as single drug treatment. 40 subjects will be enrolled; approximately 20 patients shall be included in each cohort. Subject participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. All subjects will receive Isatuximab treatment.
This is an open-label, multicenter two-arm study of Isatuximab in subjects with R/R or MRD-positive CD38 positive T-cell ALL who are at least 18 years of age. Two cohorts will be included in this study: In cohort 1 subjects with relapsed or primary refractory T-ALL will be treated with chemotherapy in combination with Isatuximab. In cohort 2 subjects with molecular failure or relapse (MRD positive) will be treated with Isatuximab as single drug treatment. 40 subjects will be enrolled; approximately 20 patients shall be included in each cohort. Subject participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. All subjects will receive Isatuximab treatment.
