Safety and Effectiveness of Tafasitamab MOR00208 in Children Ages 3 to 18 With Relapsed or Difficult-to-Treat Acute B-Cell Leukemia After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the safety, clinical toxicity, and immune effects of the antibody tafasitamab MOR00208 in children aged 3 to under 18 with relapsed or refractory acute B-lineage lymphoblastic leukemia, especially those who have persistent or new minimal residual disease MRD after stem cell transplantation or who underwent multiple transplantations. This study aims to find a new therapy approach for very high-risk pediatric patients, as current treatment options show low event-free survival rates and a high risk of relapse. The trial has two parts first, it determines the recommended dose of tafasitamab by escalating doses among participants and monitoring side effects second, it evaluates the drugs efficacy and continued safety at the established dose. Tafasitamab is given intravenously over 2 to 3 hours every two weeks during 28-day cycles, with additional doses in the first few cycles to optimize treatment. This antibody therapy is intended to reduce relapse risk after transplantation in these high-risk children. Participants will attend regular visits for treatment infusions and monitoring, including safety checks, laboratory tests, and assessments of leukemia status and immune responses. Researchers will measure time until relapse or MRD increase, drug side effects, pharmacokinetics, overall survival, and immune cell changes over follow-up periods up to approximately 18 months. Study participation involves close medical supervision to assess treatment effects and possible toxicities while aiming to improve long-term outcomes for these patients.

Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia