Phase 2 Study of Daratumumab to Clear Minimal Residual Disease in Adults with T-Acute Lymphoblastic Leukemia Who Remain Positive After Induction Chemotherapy

What this Trial Is About

Researchers are evaluating the use of Daratumumab, a monoclonal antibody, to treat patients with T-acute lymphoblastic leukemia T-ALL who remain minimal residual disease MRD positive after two courses of induction chemotherapy. This phase 2 study aims to see if Daratumumab can help these patients become MRD negative, reduce risk of progression or death at one year, and assess the safety of Daratumumab in this setting. Participants will receive Daratumumab intravenously at a dose of 16 mgkg once weekly. Initially, two doses will be given, followed by a bone marrow MRD test one week after the second dose. Patients who become MRD negative will continue standard chemotherapy as per institutional policy. Those who remain MRD positive will receive two additional weekly doses and undergo another MRD test one week after the fourth dose. Regardless of MRD status after the fourth dose, chemotherapy will continue as usual. During the study, patients will have bone marrow aspirates for MRD evaluation by flow cytometry at specified time points, along with monitoring for adverse events from the start of Daratumumab until four weeks after the last dose. Researchers will measure MRD negativity rates at week 3 and cumulative MRD negativity by week 5, as well as progression-free survival at one year. The total duration for patients who become MRD negative after two doses is about three weeks, with ongoing follow-up for safety and outcomes.

Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"