Anti-CD19-ALL

The primary study objective is to assess whether treatment with Tafasitamab prolongs the mean time to eventual hematologic relapse or increase in residual leukemia burden (MRD) or reduces the frequency of relapse.

Treatment with tafasitamab weekly or 2-weekly for a treatment period of 12 months, followed by follow-up for 6 months.

• Age 0 - 18 years
• Patients must have either undergone allogeneic stem cell transplantation with new-onset or persistent MRD post-transplant or
• Have received a stem cell transplant without having achieved sufficient molecular remission prior to transplantation (defined as MRD ≥ 10E-4) or
• Have undergone a ≥ 2nd allogeneic stem cell transplant.
• Presence of an informed consent for study participation, data collection, data storage, and data use
• Use of highly effective contraceptives in sexually active study participants.

• Open relapse ( > 5 % leukemic blasts).
• Ejection fraction less than 25 % on echocardiography
• Cystatin C clearance less than 40ml/min
• Liver failure with bilirubin > 4 mg/dl and transaminase elevation above 400 U/l
• Severe infections (HIV, chronic active viral hepatitis)
• Acute GvHD III-IV or severe chronic GvHD
• The following immunosuppressive medications (≥ 1 week): Steroids ≥ 1mg prednisolone equivalent/kg body weight, cytostatics (except intrathecal/intracerebroventricular use for CNS treatment)
• Use of other experimental therapeutic modalities in the past 4 weeks.